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Bunavail Opioid Dependence Medicine

Combating opioid dependence is a fight for your life.

BUNAVAIL is the latest opioid dependence therapy. It's the same medicine in SUBOXONE with less swallowed and less wasted.

BUNAVAIL is the first and only bi-layer buccal film. It sticks to the inside of your cheek to deliver the medicine you need efficiently, and more discreetly than other treatments.

BUNAVAIL is easy to apply to the inside of the cheek. / BUNAVAIL adheres to the inside of the cheek upon contact. / The buprenorphine in BUNAVAIL is absorbed through the inside of the cheek into the bloodstream to help you get the dose you need. / You can talk and swallow normally while BUNAVAIL dissolves.

The BUNAVAIL advantage:

  • Easy to use
  • Discreet placement
  • Stays in place
  • Allows you to talk while it dissolves
  • Pleasant citrus taste

When you decide it's time to fight back, ask your doctor about BUNAVAIL.

Using BUNAVAIL is discreet

BUNAVAIL sticks to the inside of your cheek and dissolves as it delivers buprenorphine. You’ll be able to speak and swallow normally, so taking your medication won’t get in the way of your everyday activities.

Patients agree: BUNAVAIL is easy to use and has a pleasant taste

BUNAVAIL makes treating opioid dependence easy for patients. It’s one important part of a full treatment program, which should also include counseling, medication therapy, and other remedies.

In a clinical trial:

8 out of 10
patients
who switched from
Suboxone® tablets
or films rated
BUNAVAIL as very
easy, easy, or
neutral to use.

9 out of 10
patients
who switched from Suboxone tablets or films considered the mild citrus flavor of BUNAVAIL as very pleasant, pleasant, or neutral.

Low rate of constipation in a 12-week study

68% of patients who reported constipation with Suboxone tablets or films did not report constipation at 12 weeks after switching to BUNAVAIL.

Questions and Answers

BUNAVAIL is powered by BEMA® technology

See how this important advance in the delivery of buprenorphine works.

Unique 2-layer design

BioErodible MucoAdhesive (BEMA®) technology is a buccal film with a unique 2-layer design, which easily and discreetly delivers to your bloodstream the dose of buprenorphine you need to treat your opioid dependence.

BUNAVAIL buccal film is a small yellow square with rounded corners. An inset shows the film bending up, highlighting the 2 sides—the mucoadhesive and the backing layers—of the film. The dose strength is printed on the side containing the buprenorphine in green—in this case, BN4, for 4.2 mg of buprenorphine.
  1. The top layer adheres to the inside of your cheek and contains the active drug.
  2. A backing layer acts as a barrier to help facilitate the unidirectional flow of medication to the bloodstream. This reduces the flow of buprenorphine back into the mouth, so less is swallowed.

Questions and Answers

Effective dose, efficient delivery

BUNAVAIL buccal film has twice the bioavailability of Suboxone® tablets. This means you get an equally effective amount of buprenorphine, but with half the total dose. So you’re getting the buprenorphine you need to treat opioid dependence and swallowing less medication.

The packaging for BUNAVAIL is color-coded: purple for 2.1/0.3 mg buprenorphine/naloxone, blue for 4.2/0.7 mg buprenorphine/naloxone, and orange for 6.3/1 mg buprenorphine/naloxone.

Same medication, more efficient

You may notice that BUNAVAIL is available in different dose strengths than those found in other buprenorphine treatments. That’s because BUNAVAIL, with BEMA® technology, delivers its medicine differently from other treatments. The result: You get the same amount of medicine in your bloodstream from a lower dose.

BUNAVAIL is currently available in 3 doses. Whether you are switching from Suboxone tablets or films or your initial maintenance treatment is with BUNAVAIL, the corresponding Suboxone dose is shown for your reference.

The difference in dosage strength for BUNAVAIL compared to Suboxone tablets or films is approximately half. BUNAVAIL 2.1/0.3 mg is equivalent to Suboxone 4/1mg. BUNAVAIL 4.2/0.7 mg is equivalent to Suboxone 8/2 mg. BUNAVAIL 6.3/1mg is equivalent to Suboxone 12/3 mg.

Questions and Answers

How to open a BUNAVAIL package

To open the BUNAVAIL buccal film foil package, fold along the dotted line and tear or cut with scissors at the slits of each marked corner.

  • FOLD ALONG DOTTED LINE
  • TEAR OR CUT
The packet in which BUNAVAIL is supplied tears at the corners. The edges of the packet should be folded and then torn or cut along the guide slits

How to take BUNAVAIL

Once you apply BUNAVAIL to the inside of your cheek a few times, it will become second nature. Take BUNAVAIL once a day, always exactly the way your doctor tells you. Do not take it more or less often than prescribed by your doctor. The dose of BUNAVAIL varies from one person to another and may change over time.

This image demonstrates how to hold BUNAVAIL. Hold BUNAVAIL however is most comfortable for you without dropping it, such as on the end of your finger or pinched between two fingers. Make sure the dosage strength is facing up. The printed side should be placed in contact with your cheek. / This image depicts a woman placing BUNAVAIL buccal film into her mouth. BUNAVAIL adheres upon contact with the inside of the cheek and stays in place until it dissolves. / This image shows BUNAVAIL buccal film sticking to the inside of the cheek. As BUNAVAIL dissolves, it releases buprenorphine that is absorbed by your bloodstream.
  1. Use your tongue or rinse your mouth with water to moisten the inside of your cheek before you place BUNAVAIL.
  2. Hold the BUNAVAIL buccal film with clean, dry fingers with the text (BN2, BN4, or BN6) facing up.
  3. Place the BUNAVAIL buccal film inside your mouth with the text (BN2, BN4, or BN6) against the inside of your cheek.
  4. With your finger, press the BUNAVAIL buccal film against your cheek. Hold it there for 5 seconds as it adheres.
  5. Take your finger away from the BUNAVAIL buccal film. It will stick to the inside of your cheek.
  6. Leave the film in place until it completely dissolves.
  7. If your doctor tells you to use more than one BUNAVAIL buccal film at the same time, place the next film on the inside of your other cheek following the instructions above. Do not place more than two buccal films to the inside of one cheek at a time.

Other things to keep in mind when taking BUNAVAIL

Storing BUNAVAIL

Stick to your daily routine

BUNAVAIL is easy to use and effective, but only if you stick to the routine prescribed by your doctor. So it’s a good idea to think of memorable ways to work it into your daily routine. Here are a few suggestions:

Questions and Answers

Medicines to avoid while taking BUNAVAIL

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BUNAVAIL may affect the way other medicines work and other medicines may affect how BUNAVAIL works. Some medicines may cause serious or life-threatening medical problems when taken with BUNAVAIL.

If you are pregnant or breast-feeding

Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL, tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.

Before taking BUNAVAIL, talk to your doctor if you are breast-feeding or plan to breast-feed your baby. BUNAVAIL can pass into your breast milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems. Your doctor should tell you about the best way to feed your baby if you are taking BUNAVAIL.

If you have certain liver conditions

BUNAVAIL is not recommended in patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment.

Potential side effects you should be aware of when taking BUNAVAIL

Common side effects of BUNAVAIL include:

Call your doctor for medical advice about side effects.

This is not a complete list of potential adverse events associated with BUNAVAIL.

To report negative side effects associated with taking BUNAVAIL buccal film, please call 1-800-469-0261. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Questions and Answers

Site Map

Terms of Use

Please carefully read these Terms of Use and our Privacy Policy before using our website. If you do not agree to the terms, please exit from this website immediately.

By using the BioDelivery Sciences International, Inc. ("BDSI®") website, you agree to follow and be bound by these Terms of Use and our Privacy Policy without modification and as the same may be modified by BDSI® in its discretion from time to time.

Because we will continue to seek to improve the services and features we provide on our website, BDSI® reserves the right to amendment, modify or update these Terms of Use in its discretion at any time and without notice. Any changes or updates will be effective immediately upon posting to this website. For that reason, we encourage you to review these Terms of Use periodically.

In the case of any violation of these Terms of Use, BDSI® reserves the right to seek all remedies available at law and in equity for such violation. BDSI reserves the right in its sole discretion to refuse access to its website, including, without limitation, for violations of these Terms of Use or if BDSI® believes that a visitor's conduct violates applicable law or is harmful to the interests of BDSI®.

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Use of Website/Disclaimer

The BDSI® website may contain proprietary notices and copyright information, the terms of which must be observed and followed. Information on this website may contain technical inaccuracies or typographical errors. Information may be changed or updated without notice.

YOU ASSUME ALL RESPONSIBILITY AND RISK FOR THE USE OF BDSI®'s WEBSITE AND THE INTERNET GENERALLY. THIS WEBSITE IS PROVIDED BY BDSI ON AN "AS IS" BASIS. BDSI® MAKES NO AND DISCLAIMS ALL REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, LEGAL OR EQUITABLE, AS TO YOUR USE OF THIS WEBSITE, THE OPERATION OF THIS WEBSITE OR THE INFORMATION, CONTENT OR MATERIALS INCLUDED ON OR LINKED TO THIS WEBSITE. TO THE FULL EXTENT PERMISSIBLE BY APPLICABLE LAW, BDSI® DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS OR OTHER PROPRIETARY RIGHTS, AND FREEDOM FROM ERRORS, VIRUSES, BUGS, OR OTHER HARMFUL COMPONENTS. BDSI® WILL NOT BE LIABLE FOR ANY DAMAGES OF ANY KIND ARISING FROM THE USE OF THIS WEBSITE, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OR DAMAGES RESULTING FROM LOSS OF USE, DATA, OR PROFITS, OR BUSINESS INTERRUPTION ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF THIS WEBSITE, ANY DELAYS ON THIS WEB SITE, OR THE INABILITY TO USE THIS WEBSITE, ANY PORTION THEREOF, OR ANY HYPERLINKED WEB SITE, WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF BDSI® HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

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Intellectual Property

Images and materials displayed on this website are subject to intellectual property laws. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark, or copyright owned by BDSI or any third party. Except as expressly provided herein, no use of any BDSI intellectual property rights may be made without prior written consent of BDSI. In addition, BDSI neither warrants nor represents that the use of images or materials from this website will not infringe the rights of third parties not owned by or affiliated with BDSI.

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Submitted Information

No information or material provided to BDSI® by you through our website may contain vulgar, obscene, threatening or otherwise unlawful language or material. BDSI® will not release your name or otherwise publicize the fact that you submitted materials or other information to us unless we obtain your permission to use your name or we are required to do so by law. Please review our Privacy Policy for a complete description of how we handle personal information submitted to us.

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BDSI® Information

BDSI® has made a conscientious effort to display and describe information about BDSI on the site accurately so that you can get a good idea of our business. However, the materials on this website are for your general educational information only. BDSI® does not practice medicine or provide medical services or advice, and the information on this website should not be considered medical advice. You should always rely on your health care professional for diagnosis and treatment.

Any information provided on this website is for educational and informational purposes only and not meant to be a substitute for advice offered by a physician or other healthcare professional. If medical advice or services are desired, please consult your physician or health care provider.

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Links to Other Web Sites

The BDSI® website may contain links to other websites. BDSI® is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by BDSI® of the linked website or any association with its operators. BDSI® makes no representations whatsoever about any other site you may access through www.bdsi.com. Any concerns regarding any product or service offered by a website to which the BDSI® website is linked or the link itself should be directed to the operator of that specific website and not to BDSI®. If you use these links, you are leaving this website. BDSI® has not reviewed all of these third-party sites and does not have control over, and is in no manner responsible or liable for, the availability and content of the websites to which BDSI®'s website is or may be linked. BDSI® makes no representations whatsoever about any other website you may access through www.bdsinternational.com and disclaims all liability with regard to your access to such linked websites. If you access any of the third-party sites linked to this website, you do so at your own risk.

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Children's Policy

We do not intend to collect any personally identifiable information from children through our website. Please do not allow children under the age of 13 to provide any personally identifiable information related to our website.

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Copyrights

All software and content included on this site, such as text, graphics, logos, button icons, images, audio clips, and software, is the owned or licensed property of BDSI® or its software and content suppliers and protected by U.S. and international copyright laws. The compilation (meaning the collection, arrangement, and assembly) of all content on this site is the exclusive property of BDSI® and protected by U.S. and international copyright laws. BDSI® grants you permission to view and use content and software made available to you on the site in connection with your use of the site. Any other use, including the reproduction, modification, distribution, transmission, republication, display, or performance, of the content and software on this site is strictly prohibited.

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Forward-looking Statement Safe Harbor

The content of this website contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties, including those detailed in BDSI®'s filings with the Securities and Exchange Commission.

Forward-looking statements may include, without limitation, statements regarding BDSI®'s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects”, “may”, “could”, “would”, “should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI®'s management; however, actual results, including, without limitation, actual sales results, if any, or the timing for completion and results of scheduled or additional clinical trials and FDA review of BDSI®'s formulations and products, may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve risks and uncertainties that are subject to change based on various factors (many of which are beyond the BDSI®'s control).

BDSI®'s disclaims any intent or obligation to update its forward-looking statements.

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General Terms

If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use, which shall remain in full force and effect. No waiver of any of these Terms of Use shall be deemed a further or continuing waiver of such term or condition or any other term or condition.

If you violate these Terms of Use in a way that causes harm to others, you agree to hold BDSI® harmless against any liability for that harm.

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Governing Law/Venue

These Terms of Use are governed by the internal substantive laws of the State of North Carolina, without respect to its conflict of laws principles, and the federal laws of the United States.

By using this website, you agree that all disputes arising out of or relating to your use of this website shall be brought and heard either in the North Carolina state courts located in Wake County, North Carolina, or the federal district court for the Eastern District of North Carolina located in Wake County, North Carolina. By your use of this website, you consent to the in personam jurisdiction and venue of such courts.

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PRIVACY POLICY

This Privacy Policy applies to our data collection and use practices relating to our website located at www.bunavail.com. References in this Privacy Policy to “we,” “us” or “our” refer to BioDelivery Sciences, Inc. (“BDSI”). By using our website, you agree to the terms of this Privacy Policy and any modifications made to this Privacy Policy.

Please be aware that this Privacy Policy will not necessarily apply to information you may have provided or will provide to us in settings other than by or through our website.

Collection of Information

When you use our website, we collect personal information that you choose to provide voluntarily to us. For example, you may provide personal information on a customer feedback page. In addition, when you visit our website, you will be assigned a permanent “cookie” (a small text file) to be stored on your computer’s hard drive. We may also collect certain technical information from your computer, including your Internet Protocol (IP) address, during your visit to our website. Some third party service providers may also use cookies on this website in connection with advertising or otherwise. We do not have access to or control over these third party cookies.

Use of Information

We use the information that we collect to communicate with you.

We may also use the personal information that we collect to provide you with details about promotions and services that we believe may be of interest to you, but we will only do so if you separately request, at the time of registration or at a later date, to receive these details. If you no longer wish to receive communications about such promotions and services, you may opt out at any time by notifying us at optout@bdsi.com.

We use the aggregate statistical data that we collect to better serve you. For example, we use aggregate statistical data to identify the effectiveness of our promotional activities; and provide special savings offers, such as free samples, coupons, rebates and other promotions, to you.

Sharing of Information with Third Parties

We will not sell your personal information to third parties.

We may share your personal information with our subsidiaries, affiliates, agents, representatives and business partners for the limited purpose of providing services or information to us or our customers at our direction. We may also provide to third parties certain personal information that is necessary to fulfill an order you have placed with us, such as providing your name and address to a shipping carrier for delivery. We expect our agents and business partners to follow our privacy policies when using customer information provided by us. We are not responsible for any additional information that you provide directly to these third parties.

We may also disclose the aggregate statistical data that we collect to third parties in order to allow them to measure the effectiveness of programs and advertisements aimed at our customers.

Disclosure of Information in Response to a Court Order Or in an Emergency

We will disclose information when compelled by a subpoena or court order, or when we believe, in our reasonable discretion, that such disclosure is warranted to cooperate with inquiries by law enforcement agencies or in emergencies where physical safety is at risk.

Contacting Us About Your Online Privacy

You may always contact us to remove or update personally identifiable information from our database by sending an e-mail to us at optout@bdsi.com. If you have any questions or comments about the way your personally identifiable information collected via our website is used and handled, please e-mail us at bdsi-legal@bdsi.com.

Security

We have put into place physical, electronic and managerial procedures to safeguard and secure the information we collect about you. For example, we operate secure data networks protected by industry standard “firewalls” and password protection systems that are intended to keep unauthorized persons from accessing your personal information. Nevertheless, we cannot guarantee that unauthorized access or disclosure of your personal information will never occur.

Third Party Websites

As a convenience to our website visitors, this website may contain links to third-party web sites. Third party websites are not covered by this Privacy Policy and Spectrum will have no control over the information you enter or the cookies your browser accepts while on a third party’s website. You should examine the terms of use and privacy policies of other website pages whenever you leave a Spectrum website. Spectrum is not responsible for the privacy practices or the content included on third party websites.

Amendment Or Modification of This Privacy Statement

We reserve the right to amend this Privacy Policy at any time and only the current Privacy Policy, as set forth on our websites www.bunavail.com, www.bdsi.com and www.biodeliverysciences.com will be deemed effective.

LINKING POLICY

BioDelivery Sciences International, Inc. (“BDSI”) ordinarily does not prohibit links to this website, provided that any such link does not improperly connote an endorsement by or affiliation with BDSI, or otherwise adversely impact BDSI, and pursuant to the terms below.

If you are interested in linking to this website or any other BDSI owned websites, please notify BDSI by sending an e-mail to bdsi-legal@bdsi.com. Include your name, your organization name, contact information (such as a phone number and/or e-mail address) as well as the URL of your site and a list of any URLs from which you intend to link to this site.

By linking to any page on the BDSI websites, you hereby agree to be bound by the terms and conditions as set forth below:

Links may be text-based using the words: “BUNAVAIL®”, “BUNAVAIL” , “BDSI®”, BUNAVAIL logo or any BDSI logo as a link. By linking, you acknowledge and agree that, other than as set forth herein, all rights to the BDSI Marks, other BDSI marks, the content appearing on any BDSI website and the design of any websites belonging to BDSI. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark, or copyright owned by BDSI.

You may not create frames around any of the pages of the BDSI websites or use other techniques that alter in any way the visual presentation or appearance of any of the BDSI websites.

You must not misrepresent your relationship with any BDSI product or BDSI (or any BDSI-owned business entity, BDSI subsidiary, or BDSI-affiliated business entity) or present false or misleading impressions about any BDSI product or BDSI (or any BDSI-owned business entity, BDSI subsidiary, or BDSI-affiliated business entity). No links to any BDSI website may be used in a manner that implies or suggests that BDSI approves or endorses you, your website or your goods and services (in all cases, except as BDSI may have agreed separately with you in writing). BDSI has no responsibility or liability for any content appearing on your website. You agree to indemnify and defend BDSI against all claims arising out of or based upon your website.

No link(s) may appear on any page on your website or within any context containing content or materials that may be interpreted as libelous, obscene or criminal, or which infringes, otherwise violates, or advocates the infringement or other violation of, any third party rights.

BDSI may at any time, in its sole discretion, without cause, terminate your right to link to any web pages of any BDSI website. In such event, upon request, you agree to immediately remove all links to any BDSI website and to cease using the BDSI Marks.

BDSI reserves the right to change this linking policy at any time. Changes will be posted on this page.

TRADEMARK POLICY

The tradenames, trademarks, service marks, logos, icons and trade dress of BioDelivery Sciences International, Inc. (“BDSI”), appearing on this website may not be used in any manner by users of this website without the express prior written permission of BDSI. Such tradenames, trademarks, service marks, logos, icons and trade dress, include, without limitation, BDSI®, BEMA®, BUNAVAIL® and the BDSI and the Bunavail logos, which are all trademarks owned by BDSI. All non-BDSI owned trademarks, tradenames and service marks are the property of their respective owners.

If you use the materials or trademarks on this website in a way that is not clearly allowed by this Trademark Policy, you are violating your agreement with us and may be violating copyright, trademark, and other laws. In that case, we automatically revoke your permission to use this website. Title to the materials remains with us or with the authors of the materials contained on this website. All rights not expressly granted are reserved.