Clinical Intelligence

Trevi Therapeutics announces positive results from phase II Prurigo Nodularis trial

Wednesday, October 19, 2016

Trevi Therapeutics, a late-stage clinical development company developing oral NalbuphineER for chronic pruritus conditions, has announced positive results from its phase II trial for the treatment of moderate to severe prurigo nodularis. Prurigo nodularis (PN), a severely pruritic dermatological condition characterized by itchy skin papules and nodules, has significant impact on quality of life and has no approved therapies. Trevi also previously reported statistically significant results from a robust phase II/III trial with Nalbuphine ER in hemodialysis patients with uremic pruritus.

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True North Therapeutics receives FDA Orphan Designation for TNT009

Monday, October 17, 2016

True North Therapeutics, a clinical stage biotechnology company developing novel product candidates that selectively inhibit the Complement system to treat certain rare diseases, has announced that the FDA has granted Orphan Drug Designation for the company’s lead product candidate TNT009, for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia for which there are limited treatment options available for patients.

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Sunovion receives NDA Acceptance for COPD treatment SUN-101/eFlow

Thursday, October 13, 2016

Sunovion Pharmaceuticals has announced that the FDA has accepted for review the New Drug Application (NDA) for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017.

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FDA approves Carnexiv (carbamazepine) injection for seizures

Wednesday, October 12, 2016

Lundbeck announced that the FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

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