Camurus announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Oclaiz (CAM2029), the company's investigational, once-monthly octreotide subcutaneous (SC) depot for the treatment of patients with acromegaly. The NDA submission is based on the results from a 24-week, randomized, double-blind, placebo-controlled, multi-center Phase 3 study (ACROINNOVA 1) of CAM2029 in patients with acromegaly who were biochemically controlled on stable treatment with standard of care. The NDA is further supported by data from a 52-week, open-label Phase 3 study (ACROINNOVA 2) of long-term safety and efficacy during treatment with CAM2029 in patients with acromegaly who were biochemically uncontrolled or controlled on standard of care at study entry.
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- Camurus AB Submits New Drug Application to the US FDA for Oclaiz for Treatment of Acromegaly