Pfizer and Acura's tamper resistant opioid Oxecta gets US FDA approval

After a significant delay, drugs behemoth Pfizer (NYSE: PFE) and partner Acura Pharmaceuticals (Nasdaq: ACUR) have finally received marketing approval from the US Food and Drug Administration for Oxecta, a tamper-resistant formulation of oxycodone. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Acura’s shares rocketed more than 50% to $5.82 in morning trading yesterday on the news,  though closed the day just 16% higher at $4.50, as Cowen & Co analyst Ian Sanderson quoted by Bloomberg cautioned that the drug’s annual sales could be limited to around $30 million because it does not guard against intentional overdose. However, Citigroup analyst John Boris sees peak sales reaching $100 million a year. Acura benefits from a $20 million on the FDA approval.

The product, formerly known as Remoxy and under development by Pain Therapeutics and King Pharmaceuticals, the $3.6 billion acquisition Pfizer completed earlier this year, was turned down by the FDA last year but was later re-submitted to the agency in a new formulation with Acura (The Pharma Letter January 4).