WASHINGTON (AP) – The Food and Drug Administration has questions about whether a painkiller from Acura Pharmaceuticals designed to discourage abuse will actually stop patients from misusing the pill.
Acura and partner King Pharmaceuticals are asking the FDA to approve Acurox, which combines oxycodone with the vitamin niacin. The vitamin is designed to cause nasal irritation and flushing if patients take an excessive dose of the pill while trying to get high.
But in a review posted online Tuesday, the FDA said company studies “suggest niacin offers little in the way of deterrence to oral abuse.”
FDA reviewers also questioned whether the amount of flushing caused by normal use of Acurox could discourage patients from taking the drug. As many as 16 percent of patients taking Acurox reported “feeling hot,” after taking the pill, compared with less than 5 percent of patients on placebo.
Shares of Acura Pharmaceuticals plummeted $1.67, or 21.1 percent, to close at $6.23 Tuesday.
FDA will ask a panel of experts on Thursday whether they recommend approval of the drug. The agency is not required to follow the group’s advice, though it often does. A final decision is expected by June 30.
Oxycodone is the active ingredient in Purdue Pharma’s best-selling painkiller OxyContin, which 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. Bristol, Tenn.-based King will manufacture and market the drug, paying royalties to Acura.
Date: April 20, 2010
Source: Associated Press
Filed Under: Drug Discovery