Regulatory

insys Therapeutics' epinephrine nasal spray for the treatment of anaphylaxis has received Fast Track designation from the FDA, the company said. In June 2018, Insys said that a Phase 1 study of the nasal spray showed that its bioavailability was similar to that of intramuscular formulations. The company has several OINDPs in development, including a dronabinol … [Read more...] about Insys gets Fast Track designation for its epinephrine nasal spray

Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now received the letter from the FDA and believes that the company can satisfy the FDA's requirements. According to MVP, the FDA is requiring the … [Read more...] about MVP says it believes it can meet FDA requirements for Penthrox IND

The FDA has granted fast track designation to NeuroproteXeon (NPXe) and Mallinckrodt’s inhaled xenon gas for the treatment of post-cardiac arrest syndrome (PCAS), the companies said. A Phase 3 trial of inhaled xenon for that indication is expected to get underway in the next few months. NPXe’s Xenex inhaled xenon has received orphan drug designation from the FDA … [Read more...] about Inhaled xenon gas for PCAS gets fast track designation

Evoke Pharma has announced that the FDA has accepted the company's 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June 2018. The PDUFA date has been set for April 1, 2019. In a separate letter, the agency also informed Evoke that it had conditionally … [Read more...] about Evoke’s NDA for Gimoti accepted for review by the FDA

According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March 31, 2019 for both applications. The Tudorza sNDA requests to add COPD exacerbation reductions and cardiovascular safety data to the prescribing … [Read more...] about FDA accepts NDA for Duaklir, sNDA for Tudorza

US-based Onspira Therapeutics has announced that its OSP-101, an inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans, has been granted orphan drug designation by the FDA. Onspira is a private company created by NeXeption in 2017, and OSP-101 is currently its only candidate. Onspira Therapeutics President and CEO Brian … [Read more...] about Onspira’s inhaled therapy for bronchiolitis obliterans gets orphan drug designation

UCB announced that the FDA has accepted its new drug application for USL261 midazolam nasal spray for the rescue treatment of seizures in epilepsy patients. The company announced in April 2018 that it had acquired rights to the nasal spray from former Upsher Smith subsidiary Proximagen. USL261 has previously received both orphan drug designation and fast track … [Read more...] about UCB’s midazolam nasal spray NDA accepted by the FDA

The FDA has accepted Glenmark Pharmaceuticals' NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019, the company said. Glenmark announced submission of the NDA in May 2018. Positive results from Phase 3 studies of Ryaltris … [Read more...] about FDA accepts NDA for Ryaltris, sets PDUFA date