Princeton, New Jersey, February 19, 2019 – Sandoz, a Novartis division, today announced that the authorized generic of SUBOXONE® 1 (buprenorphine and naloxone) Sublingual Film (CIII)by Indivior Inc. in all four dosage strengths is immediately available in the US.
Sandoz buprenorphine and naloxone sublingual film (2mg/0.5mg, 4mg/1mg, 8mg/2mg and 12mg/3mg) is indicated for the treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
"We are excited to have the opportunity to further increase access to this critical medicine in the US market and to be a part of the solution to a healthcare crisis that the nation is facing,” said Carol Lynch, President of Sandoz Inc. “Sandoz is well-positioned to deliver another important treatment alternative for patients suffering from addiction.”
As part of this effort, Sandoz is commercializing FDA-cleared prescription digital therapeutics as an adjunct to outpatient treatment to help patients with substance use disorder and opioid use disorder. Sandoz is also working with other partners and healthcare professionals to help address substance and opioid abuse, which requires a collaborative effort between all stakeholders, including regulatory authorities, physicians and other healthcare providers.
According to IQVIA, US sales for SUBOXONE were approximately USD 2 billion for the period ending December 2018 (MAT: Moving Annual Target).
1 SUBOXONE is a registered trademark of Indivior UK Limited.
Important Safety Information
Hypersensitivity to buprenorphine or naloxone.
Warnings and Precautions
• Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.
• Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with buprenorphine and naloxone sublingual film.
• Unintentional Pediatric Exposure: Store buprenorphine and naloxone sublingual film safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
• Neonatal Opioid Withdrawal Syndrome: Neonatal Opioid Withdrawal Syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
• Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
• Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.
• Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid withdrawal syndrome is likely to occur with parenteral misuse of buprenorphine and naloxone sublingual film by individuals physically dependent on full opioid agonists, or by sublingual or buccal administration before the agonist effects of other opioids have subsided.
• Risk of Overdose in Opioid-Naïve Patients: Buprenorphine and naloxone sublingual film is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2mg sublingual dose.
Adverse events commonly observed with the sublingual/buccal administration of the buprenorphine and naloxone sublingual film were oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
• Benzodiazepines: Use caution in prescribing buprenorphine and naloxone sublingual film for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse.
• CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under-dosing.
• Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if non-nucleoside reverse transcriptase inhibitors are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and dose reduction of buprenorphine may be warranted.
• Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue buprenorphine and naloxone sublingual film if serotonin syndrome is suspected.
Use in Specific Populations
• Lactation: Buprenorphine passes into mother's milk.
• Geriatric Patients: Monitor for sedation and respiratory depression.
• Moderate or Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “drive,” “potential,” “well-positioned,” “can,” “will,” “plan,” “expected,” “anticipate,” “look forward,” “believe,” “commitment,” “investigational,” “pipeline,” “portfolio,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, launches, new indications or labeling for authorized generic Buprenorphine & Naloxone sublingual film 8mg/2mg and the other investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that authorized generic Buprenorphine & Naloxone sublingual film 8mg/2mg or the other investigational or approved products described in this release will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional competing versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our broad portfolio, covering all major therapeutic areas, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.