Pharma major Dr. Reddy’s Laboratories Ltd. has received final approval from the U.S. Food and Drug Administration (USFDA) for launching Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film.
The product is being launched in the U.S. with an approved Risk Evaluation and Mitigation Strategy (REMS) Programme. The Suboxone brand had sales of around $1.86 billion MAT in the U.S. for 12 twelve months ended April 2018, the company said citing IMS Health.
Buprenorphine and naloxone are used to treat adults with opioid dependence/addiction. While Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment programme, including prescription monitoring, counselling, and psychosocial support, the release said.
“With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients,” said Alok Sonig, CEO (Developed Markets) of the Hyderabad-headquartered firm.
Stating that the regulator's approval for the product was an “important milestone for our company,” he said Dr.Reddy's would continue to look for opportunities to acquire and manufacture assets that accelerated access to innovative and affordable medicines for patients.
The release from the company also referred to the USFDA Commissioner Scott Gottlieb's statement in which he spoke of new steps the regulator was taking to advance the development of improved treatments for opioid use disorder and to make sure these medicines were accessible to the patients who needed them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”