FDA accepts Elite's OxyQD IND
US firm Elite Pharmaceuticals says that the Food and Drug Administration has accepted the Investigational New Drug application for its once-daily oxycodone-based pain management drug, OxyQD.
The IND, which was submitted to the FDA in December 2005, allows Elite to conduct a Phase I clinical study of the drug comparing patient absorption of oxycodone derived from QxyQD with that from its currently- available, twice-daily oxycodone product OxyContin.
The IND for OxyQD is the company's second to gain FDA acceptance in recent months. The firm's opioid resistant product OxyNal, which was submitted for FDA consideration in the second quarter of 2005, is currently in clinical trials and has produced positive initial results (Marketletter April 28, 2005).
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