FDA approves Teva’s higher-dose opioid dependence therapy

US regulators have approved Teva’s under-the-tongue film Cassipa for maintenance and treatment of opioid dependence. The decision gives a new dose strength of 16 milligrams and 4 milligrams of the respective active ingredients, buprenorphine, and naloxone. With an opioid addiction crisis gripping many parts of the US, the FDA is looking for treatments for opioid dependence to help wean patients off the powerful painkillers, as well as alternative non-addictive painkillers. Cassipa will be used as part of a Medication-assisted treatment (MAT) – a comprehensive approach combining FDA-approved drugs – methadone, buprenorphine, or naltrexone – with counseling and other behavioral therapies to treat patients with opioid use disorder.