Camurus said Monday that the United States District Court for the District of Columbia granted Braeburn’s motion for summary judgement, vacating the U.S. Food and Drug Administration’s (FDA) decision to block final market approval of Brixadi Monthly.
Camurus said the court has ruled that, in December 2018, the FDA acted inconsistently with precedent by delaying the approval of Brixadi and granting a three-year exclusivity to Sublocade. The case is remanded to the FDA to reconsider, with deliberate speed, Braeburn’s application for final approval of Brixadi Monthly, Camurus said.
Fredrik Tiberg, CEO and Head of R&D of Camurus said: “The court’s decision is highly important to Camurus, both commercially and in principle. We look forward to seeing the FDA act with deliberate speed in accordance with the court’s decision, to give US patients earlier access to Brixadi and thereby contributing to reducing the detrimental impacts of the ongoing opioid crisis.”