If only it were so easy. Acura's big problem is that niacin is the key ingredient in the abuse-resistant technology used in the pain drug Acurox. Without niacin, drug abusers can swallow excess Acurox tablets to get high. Niacin-less Acurox would still contain ingredients to prevent abuse by crushing or dissolving the tablets, but there are already FDA approved oxycodone formulations on the market that do the same thing.
Last week's FDA advisory panel on Acurox was very clear in its dislike for niacin as a way to prevent prescription drug abuse. The panel's strong vote against recommending Acurox's approval coupled with the FDA's negative opinion on the drug means two things: 1) Acurox in its current formulation is not getting approved; and 2) Acura will most likely need to return to the lab and completely rework its abuse-resistant technology if it ever wants to get any of its pipeline products approved.
I'm surprised Acura hasn't held a conference call yet to discuss the FDA advisory panel decision. King Pharmaceuticals (KG), Acura's marketing partner, seems to be driving this train, but aren't the odds high that King dissolves the Acura partnership given niacin's dead end?
Alex M. writes, "A colleague mentioned he had been persuaded to buy Pro-Pharmaceuticals (PRWP.OB) a few years back, and after years of languishing in losses, he's wondering whether it's actually a real company with a real drug candidate, Davanat, or whether it's an out-and-out scam or somewhere in between... Do you have a view on this company? I'm a huge admirer of your column, and have to admire anyone who flushes CEOs of companies like Generex (GNBT) and Cell Therapeutics (CTIC) out of the woodwork in the way you have. I suspect that makes you eminently qualified to comment on Pro-Pharmaceuticals."I called the public relations people working with Pro-Pharma on Wednesday asking for slides and/or published articles so that I could review the phase II data on Davanat in colon cancer, the drug's lead indication. Pro-Pharma's spokeswoman explained to me the company hasn't presented or published any of the Davanat data (from a study conducted in 2004-2006) because the FDA places "serious restrictions" on publishing clinical data without the agency's approval.
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