Pfizer Inc. isn’t throwing in the towel just yet on its experimental painkiller Remoxy, an extended release formulation of oxycodone that has been held up for years because of regulatory concerns.
The company says it will run new clinical trials of Remoxy, a drug designed to be harder to abuse than older oxycodone formulas. Remoxy capsules contain oxycodone in a thick liquid form, which makes them harder for drug addicts to crush and snort.
Pfizer Inc. (NYSE: PFE) said it made its decision after receiving guidance from the U.S. Food and Drug Administration, which refused to approve Remoxy in 2008 and 2011. The new clinical trials will study the abuse potential of a modified Remoxy capsule and whether it is bioequivalent to it original formulation.
The company doesn’t expect to file for FDA approval again until 2015.
Remoxy was initially developed by Pain Therapeutics (NASDAQ: PTIE), using DURECT Corporation’s (NASDAQ: DRRX) technology, which is designed to discourage common methods of tampering.
“We are pleased that, after a thorough review and having achieved technical milestones, Pfizer is proceeding with development of Remoxy,” said James Brown, President and CEO of DURECT. “We continue to believe that Remoxy could play an important role in serving the needs of chronic pain patients while potentially reducing the misuse and abuse of oxycodone.”
Pain Therapeutics will get a $15 million payment from Pfizer if the FDA approves Remoxy. It would also receive royalty payments of 15% on the first $1 billion in domestic Remoxy sales and 20% after that.
Pain Therapeutics said it had also regained the rights to three abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone. The company said new drug applications for all three painkillers were already on file with the FDA.
“We are now free to develop and commercialize these assets on our own or with a licensee of our choice,” Pain Therapeutics said in a statement.
“We have not yet made a decision to develop or to out-license the three drug assets.”
Suboxone Unit Could Be Sold
While Pfizer is doubling down on its development of Remoxy, another company may be getting out of the drug making business altogether.
British consumer goods giant Reckitt Benckiser – the maker of Suboxone — said it may put its pharmaceutical unit up for sale.
Suboxone, which is used to treat addiction to heroin and opioid painkillers, has been a potent money maker for Reckitt. Since its introduction in 2003, Suboxone has been used to treat over three million Americans with opioid dependence.
However, Reckitt’s tablet formula for Suboxone went off patent in 2009 and the company faces increasing competition from generic competitors. Reckitt had warned shareholders last year that “up to 80% of the revenue and profit from the suboxone tablet business in the U.S. might be lost” to generic competition.
A sublingual film version of Suboxone is still patent protected and accounts for a growing share of Reckitt’s $1.5 billion in Suboxone sales.
According to one estimate, Reckitt’s pharmaceutical unit could be worth over $3 billion.