For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic versions of the highly addictive OxyContin on the market versus the benefit of consumers with pain issues having access to cheaper meds. Legislators and law enforcement officials reasoned and pleaded with, or threatened, the FDA over approving them. Today as Purdue Pharma's patent for the original OxyContin expired, the FDA came down on their side, saying "the benefits of original OxyContin no longer outweigh its risks" and banned any copies from approval.
The FDA decision does not mean patients will lose access to the benefits of the drug. They will just not be able to get cheaper versions. In 2010, Purdue brought out a reformulated version, which it spent about $100 million developing. That version, which is harder to crush and so harder to abuse, is still on the market. It then quit selling the original version, which had become a popular drug for abuse. It has patent protection on the reformulated version until 2025.
It is tough news for the generics makers that were ready to go with copies. Impax Laboratories ($IPXL) and Mallinckrodt, the generic division of Covidien ($COV), along with Teva Pharmaceutical Industries ($TEVA), had lined up for approval of generics of the popular pain drug. For now those applications have been halted. The FDA said, "the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin."
On the other hand, it is good news for companies like Grünenthal Group, a German company that specializes in tamper-resistant pain products. Purdue uses Gruenthal intellectual property in its tamper-resistant OxyContin. In a telephone interview from Germany, CEO Harald Stock, told FiercePharma, "I think this is very positive, both in terms of addressing a serious public health issue and providing access to innovative pain medications. This is a landmark decision by the FDA." He said it was not only important that the FDA was keeping generics of the original formulation off the market but also allowing those companies with tamper protected formulations to make a "label claim."
Stock said draft guidance the FDA put out in January also shows the way forward for this thorny issue. "I think all of the participants in this part of the business, the onus is on us to to provide patients with drugs with the maximum safety to avoid abuse, while insuring that the 10% to 12% of Americans who suffer from chronic pain have access to the pain medications they need."
The FDA is urging drugmakers to develop more tamper-resistant pain meds to meet those needs. "The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Dr. Douglas Throckmorton, deputy director for regulatory programs at FDA's CDER, said today.
There is evidence that tamper-resistant versions can keep some addicts from using them. Citing IMS Health stats, The Wall Street Journal reported Monday that when OxyContin was reformulated, its sales dropped 7% in the first year while sales of an unreformulated painkiller from Endo Pharmaceuticals ($ENDP) rose 72%. Then when Endo remade its Opana, the new drug's sales dropped 25%. The patent on Opana ER expired recently.
- here's the FDA announcement
- read the WSJ story (sub. req.)