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news.BioDelivery Sciences International, a specialty pharmaceutical company, has received a complete response letter from the FDA regarding the company's new drug application for Bema Fentanyl, which will be marketed in the US as Onsolis.
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The FDA has requested that the company make modifications to the submitted risk management program. All aspects of the review were complete and no deficiencies were noted in chemistry, manufacturing and controls, nonclinical, or clinical efficacy and safety. The company will submit the requested information and anticipates approval in the first half of 2009.
The FDA has requested conversion of the risk minimization action plan submitted as part of the new drug application (NDA) for Onsolis into a risk evaluation and mitigation strategy (REMS).
Onsolis is said to be a potential treatment for breakthrough pain in opioid tolerant patients with cancer.
Mark Sirgo, president and CEO of BioDelivery Sciences, said: “We have been anticipating the REMS request and have been proactively evaluating a series of options that will enable us to mitigate any delay in approval. All other aspects of our Onsolis NDA were reviewed positively and with no deficiencies noted.”