FDA taking on pain drugs' knotty issues
When an FDA expert panel recommended against a stronger form of hydrocodone from Zogenix ($ZGNX) this month, it said it was best if the FDA would first consider requiring ways to discourage abuse of opioids. The agency intends to do just that.
The FDA will hold a two-day meeting in February to take a look at "scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain." As Regulatory Focus points out, that will encompass questions such as whether pain drugs should be prescribed for limited durations, whether those durations should be different for various kinds of pain, say back pain versus cancer pain, and whether there should be a maximum daily dose.
At $9 billion a year, the prescription pain drug market can be quite lucrative, but the use, and abuse, of pain meds means the category is fraught with strong opinions. Purdue Pharma reworked its OxyContin formula to make the powerful opioid pills more difficult to crush or dissolve by addicts. Endo Pharmaceuticals ($ENDP) did something similar with its Opana painkiller. Congress has been considering whether to give the FDA authority to yank regulatory approval for generic drugs that aren't redesigned with such safety features. The patents are set to expire on both of those drugs next year, and the companies see the new formulations as a potential patent protector. Endo recently sued the FDA to have it classify its original formulation unsafe and require generics makers to go the tamper-resistant route, a move that would delay competition.
Meanwhile, Zogenix is hoping the agency will still approve its Zohydro, a drug that contains 50 mg of hydrocodone, 10 times the dose of Vicodin.
- read the Regulatory Focus story
- more from Bloomberg
- here's the FDA notice