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 counselling and other behavioural therapies to treat patients with opioid use disorder.

Adhering to the treatment reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.

At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued abuse less attractive.

Figures from the US Substance Abuse and Mental Health Services Administration (SAMHSA) show receiving MAT cuts risk of death from all causes in half.

Cassipa is Teva’s higher-dose version of Indivior’s Suboxone sublingual film, and while it is therefore not a generic, its filing was based on safety and efficacy data from Suboxone, as well as pharmacokinetic data showing that the higher-dose formulation is safe and effective.

FDA commissioner Scott Gottlieb said: “There’s an urgent need to ensure access to, wider use and understanding of, medication-assisted treatment for opioid use disorder.”

“The introduction of new treatment options has the potential to broaden access for patients. For example, the FDA recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine.”

“This streamlined approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment.”