Teva holding off launch of opioid addiction drug
Teva is to hold off launching its higher dose version of Indivior’s blockbuster opioid addiction drug, Suboxone (buprenorphine and naloxone).
As reported by pharmaphorum earlier this week, US regulators quickly approved the therapy to provide another alternative for patients seeking to shake off opioid addiction.
But Reuters reported that Teva has decided not to launch until another court case, where the Israel-based drugmaker is trying to prevent the launch of a generic version produced by India’s Dr Reddy’s Laboratories.
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.
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 the risk of death from all causes in half.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.