“The company has received final approval from the (USFDA) and is 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, in the United States market. The product is being launched with an approved risk evaluation and mitigation strategy (REMS) program,” Dr Reddy’s Laboratories said in a press release.
Buprenorphine and naloxone are used to treat adults with opioid dependence/addiction. Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment program including prescription monitoring, counseling, and psychosocial support.
According to IMS Health, the Suboxone brand had U.S. sales of approximately $1.86 billion MAT for the most recent twelve months ending in April 2018.
At 09:27 am; Dr Reddy’s was trading 2.8% higher at Rs 2,331 on the BSE, as compared to 0.1% rise in the S&P BSE Sensex. A combined 830,824 shares changed hands on the counter on the BSE and NSE so far.