Acura Pharmaceuticals' two-and-a-half year saga to get a new opioid painkiller approved by the FDA has finally been capped with success. Late Friday the agency quietly handed out an approval for Oxecta, a reformulated version of Acurox that had to be resubmitted last year after an advisory committee turned their thumbs down on the painkiller, which was then partnered with King Pharmaceuticals. King was acquired by Pfizer, which now has marketing rights for the treatment.
Shares of Acura rocketed up more than 50 percent this morning as news of the approval was officially released. In addition to royalties on the painkiller, which is designed to be a tamper-resistant version of oxycodone, Acura also nailed a $20 million milestone from Pfizer.
"We are excited to be partnered with Pfizer to bring Oxecta to patients who need opioids to manage their pain," said Robert Jones, interim president and chief executive officer of Acura Pharmaceuticals. "Acura is focused on developing technologies that are intended to potentially deter abuse and misuse."
In April of 2010 an FDA committee determined that the drug's anti-abuse properties weren't strong enough to warrant approval. In addition to properties that prevent the drug from being abused, Acura and King had added niacin to Acurox, which causes uncomfortable flushing if too many pills are taken.
- check out the Acura release
- see the Reuters story