In what has been termed a national epidemic, the FDA on Wednesday issued draft guidance supporting the development of drugs with abuse-deterrent properties, hoping to stem the tide of an estimated 15,000 plus deaths a year. In its guidelines, the FDA has emphasized that FDA it "will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products." This is a potential boon for Intellipharmaceutics (NASDAQ:IPCI), which is well-positioned to take advantage of what is estimated to be a US$2.5 billion market with its new and unique patent-pending technology "Rexista™."
Rexista™ is formulated to work with opioids, notably oxycodone products, in such a way as to prevent abuse by injection, inhalation or oral ingestion. In a common form of abuse, Oxycodone is often paired with alcohol, which can prove to be a lethal combination. Rexista™ is designed to keep the entire dose from being released when alcohol is present in the user's system, negating the effects that systematic abusers hope to achieve.
"The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," said FDA Commissioner Margaret A. Hamburg, M.D. "This draft guidance is an important part of a larger effort by the FDA aimed at preventing prescription drug abuse and misuse."
While the arena of drug deterrent technology is relatively new and rapidly expanding, IPCI's efforts are well under way, having achieved positive results in Rexista™ pilot studies completed in May of 2010.
With the FDA pushing to get solutions into the marketplace, pharmaceutical companies such as IPCI may have an edge with the substantial clinical pilot work they have already completed. Dr. Douglas Throckmorton, Deputy Director for Regulatory Programs in the FDA's Center for Drug Evaluation and Research said, "The agency believes that new technologies that are effective in decreasing abuse are very important for us to incentivize. It's the reason why we are putting this draft guidance out - to work to encourage the development of these formulations." Given the favorability of these regulatory policies, IPCI's Rexista™ is one to watch.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: ProActive Capital Resources Group has received compensation from IPCI to provide research and investor relations coverage for a period of time.