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FDA accepts Elite's IND for Oxycodone product
By Lisa Kerner
Erie, Pa., Jan. 31 - Elite Pharmaceuticals, Inc. said the Food and Drug Administration has accepted its Investigational New Drug application for the once-daily oxycodone product, OxyQD. The company submitted the IND in late December.
Under the IND for OxyQD, Elite will conduct a pilot phase 1 study using its sustained-release formulation, according to a company news release. The study will evaluate the extent of absorption of oxycodone from OxyQD compared to a current commercial oxycodone product, OxyContin, a twice-a-day opioid product.
OxyQD uses Elite's proprietary sustained release technology. Elite's technology for once-a-day oxycodone is protected by a patent pending.
This is the second IND approval for Elite within the past 12 months. The first IND was for Elite's opioid abuse-resistant product, OxyNal.
"By providing a once-daily oxycodone, we will be offering the medical practitioner practical alternatives to treat and manage moderate to severe chronic pain which addresses a large unmet medical need. The acceptance of our IND for a once-daily oxycodone, coupled with the positive clinical trial results for our abuse resistant oxycodone OxyNal, are significant technical achievements for Elite," chairman and chief executive officer Bernard Berk said in the release.
There is no once-daily oxycodone on the market, the company said. The annual U.S. market for sustained release, twice-daily oxycodone was approximately $2 billion as of the end of September.
Elite, located in Northvale, N.J., is a specialty pharmaceutical company engaged in the development of oral, controlled-release products.
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