FDA Panel: Acura Pharmaceuticals'Acurox Acura Pharmaceuticals (ACUR) brings its abuse-resistant painkiller Acurox in front of an advisory committee of the U.S. Food and Drug Administration today.
Acurox is a short-acting drug that consists of the powerful painkiller oxycodone combined with niacin and other ingredients that Acura says deters common methods of prescription drug tampering and abuse.
is Acura's marketing partner.
FDA convened today's panel to get
because the agency has concerns about the use of niacin to deter abuse. In briefing documents released Tuesday, FDA reviewers concluded that, "niacin offers little in the way of deterrence to oral abuse," in part because the aversive effects of niacin can be defeated if a person eats a high-fat meal or takes aspirin.
The advisory panel will also be asked to consider whether the side effects of niacin -- mainly flushing, headaches and chills -- are a risk for patients who take Acurox according to their doctor's instructions.
Acura believes that opioid abuse is a major public health problem and for that reason, Acurox was designed to relieve moderate-to-severe pain and minimizethe potential for opioid abuse by the three most common methods: oral (when taken atdoses higher than recommended); intranasal (nasally snorting crushed tablets); and intravenous (IV injection of dissolved tablets).
For those interested, briefing documents for today's
Acura FDA meeting
, including the FDA's review and Acura's presentation, can be found on the FDA's web site.
-- Reported by Adam Feuerstein in Boston.
Follow Adam Feuerstein on
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
to send him an email.