WASHINGTON (AP) – Federal health experts said overwhelmingly that an experimental painkiller designed to discourage misuse is not effective enough to warrant approval.
A panel of Food and Drug Administration experts voted 19-1 against Acura Pharmaceutical’s Acurox, which combines the narcotic oxycodone with the vitamin niacin. The extra ingredient is designed to cause irritation and flushing if patients take excessive doses needed to achieve euphoric effects.
But panelists were unconvinced by the company’s data, which they said did not show strong evidence that niacin discouraged abuse.
Panelists pointed out that the negative effects of niacin could be eliminated simply by eating food or taking aspirin. Some of the experts said the drug could be approved if the niacin was removed.
The FDA is not required to follow the advice of its panelists, though it often does. A final decision is expected by June 30.
If approved the drug would be manufactured and marketed by partner King Pharmaceuticals, with Acura receiving royalty payments.
Acura shares plummeted $2.51, or 42.5 percent, to $6.25 in afterhours trading.
King’s chief science officer, Dr. Eric Carter, noted that the panel said the company’s concept was sound, but lacked data to show it would curb painkiller abuse.
“We presented some data which we thought exceeded the threshold and the committee said ‘no,’ they needed us to climb further up the mountain,” said Carter, in a telephone interview with The Associated Press.
“We always learn from these panels because they help set up the threshold for approval,” he added.
Oxycodone is the same ingredient found in Purdue Pharma’s painkiller OxyContin. The blockbuster drug is designed to be a time-release painkiller but is often crushed, snorted or melted to get a massive, euphoria-inducing dose. Such abuse can result in overdose and occasionally death.
The FDA has issued a number of warnings on prescription pain relievers over the years but with little success. More recently regulators have begun urging companies to make their drugs more difficult to abuse.
King, which is based in Bristol, Tenn., has already launched one such drug called Embeda. Another drug from the company called Remoxy is under FDA review.
Acurox is different from those drugs in that it is an immediate-release drug instead of an extended-release one. Acura and King have said immediate-release opioids are abused about 10 times as often as extended release drugs.
Palatine, Ill.-based Acura develops technology to make drugs harder to tamper with. If approved, Acurox will be its first product to reach the market. King will manufacture and market the drug, paying royalties to Acura.
Eds: CORRECTS Carter’s affiliation. ADDS stock prices.
Filed Under: Drug Discovery