FDA approves Pfizer, Acura's pain drug Oxecta

Pfizer and Acura Pharmaceuticals announced Monday that the companies received FDA approval for Oxecta (oxycodone) as a treatment for patients with acute and chronic moderate-to-severe pain where the use of an opioid analgesic is appropriate. The companies noted that the product is the first immediate-release form of oxycodone "designed to discourage common methods of tampering associated with opioid abuse and misuse."

Pfizer licensed the technology used in the drug from Acura, is expected to begin selling Oxecta late in the third quarter or early in the fourth quarter. The FDA is requiring the drugmaker to conduct a study to examine whether the analgesic decreases the consequences of abuse and misuse.

However, Cowen & Co. analyst Ian Sanderson warned that sales of the drug may be limited to $30 million a year because it doesn’t guard against intentional overdose. "While the Acura technology does prevent them from being crushed and snorted and chewed, the primary means of abuse is still wide open," adding that Oxecta "really does not have a lot of commercial potential." Meanwhile, Citigroup analyst John Boris said that he expects Oxecta to be an incremental opportunity for Pfizer with peak sales of about $100 million.

Acura noted that it will receive a milestone payment of $20 million from Pfizer, sending shares up as much as 75 percent.

  • The pharmaceutical industry is lagging behind on the use of Closed Loop Marketing -- find out why.

Closing the Loop: Beyond Digital Detailing - click here to find out more.

To read more Top Story articles, click here.