Vivitrol to treat opioid dependence will come to the markets in six month’s time.
In addition to the use of heroin, an illegal opioid, opioid dependence includes the non-medical use of opioid analgesics approved by the U.S. Food and Drug Administration (FDA).
Vivitrol contains the drug naltrexone in extended-release injectable form.
In 2006, US FDA approved Vivitrol as once-monthly, extended-release injectable medication for the treatment of alcohol dependence.
If approved for opioid dependence, Vivitrol would be the first and only non-narcotic, non-addictive medication for the treatment of opioid dependence available in a once-monthly formulation.
Alkermes studied Vivitrol for six-months in a multi-center, randomized phase 3 clinical trial for opioid dependence.
Data from the study showed that patients treated once-monthly with Vivitrol demonstrated higher rates of opioid-free urine screens, compared to patients treated with a dummy pill.
Patients taking Vivitrol had 90 per cent opioid-free urine screens during the evaluation phase
Patients treated with Vivitrol also showed a significant reduction in opioid craving.
Vivitrol was generally well tolerated in the study and no patients on VIvItrol discontinued the study due to side-effects.
The most common side-effects experienced by patients receiving Vivitrol during the study were nasopharyngitis and insomnia.
Alkermes, Inc’s Vivitrol may get a comparatively earlier approval from the US drug regulator as it has been given a priority review status.
The designation is assigned to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists and accelerates the US FDA’s target review timeline from ten to six months.
“We are very encouraged by the US FDA’s decision to grant priority review for Vivitrol for opioid dependence. The designation further supports the existence of a high unmet need for alternative therapies for patients with this chronic disease,” stated Richard Pops, chief executive officer at Alkermes.
Opioid dependence is a serious disease affecting approximately two million people in the U.S.
There are few approved medications available for treating opioid dependence and no approved long-acting antagonist therapies.
Alkermes is a biotechnology company Alkermes focusing on therapies for widespread, chronic diseases, such as central nervous system disorders, addiction, diabetes and autoimmune disorders, where we feel we have the opportunity to make the greatest impact.