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news.The US Food and Drug Administration (FDA) has issued a Complete Response Letter (the “CRL”) regarding Elite Pharmaceuticals' New Drug Application (the “NDA”) for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride) investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
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The FDA issues CRLs to indicate that the Agency considers the review cycle for an application is complete and whether the application is ready for approval in its present form.
CRLs often include guidance that describes deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval. The CRL determined that the NDA was not ready for approval in its present form.
“We are evaluating the CRL received and hope to meet as soon as possible with the FDA to discuss how to address their concerns. We will work closely with the FDA to determine the appropriate next steps and path forward for the NDA,” said Nasrat Hakim, President and CEO of Elite.
After the Company has met with the FDA and the Agency is able to provide greater clarity to the issues raised in the CRL, Elite will host a conference call to discuss the pathway forward for SequestOx.
Elite Pharmaceuticals is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry.
Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and the NDA for SequestOx, for which it just received the CRL from the FDA.