Medical

Biohaven Pharmaceutical said that it has initiated a Phase 2/3 study of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist for the treatment of migraine. The company announced positive results from a Phase 1 study of BHV-3500 in February 2019. The trial will compare 5, 10, and 20 mg doses of BHV-3500 delivered by Aptar Pharma's Unit … [Read more...] about Biohaven initiates Phase 2/3 study of BHV-3500 intranasal therapy for migraine

The Alzheimer’s Drug Discovery Foundation has awarded a grant worth approximately $1.2 million to a team led by Hiroaki Sato and Thomas Schricker at the Research Institute of the McGill University Health Centre (RI-MUHC) for research into the effectiveness of intranasal insulin for delirium and cognitive dysfunction experienced by patients following surgery. Sato … [Read more...] about McGill University team gets funding for project evaluating intranasal insulin for postoperative cognitive impairment

Auris Medical has announced the initiation of a Phase 1b proof-of-concept study of its AM-201 intranasal betahistine, which the company is developing for the prevention of weight gain and sleepiness in patients taking olanzapine. The 4-week dose escalation study is expected to compare 5 different doses of AM-201 to placebo in 50 healthy volunteers who will also … [Read more...] about Phase 1b trial of Auris Medical’s intranasal betahistine gets underway

Mundipharma has announced enrollment of the first patient in the Phase 3b METEORA trial of Penthrox inhaled methoxyflurane in patients with limb trauma who have been rescued by helicopter from hostile terrain and are suffering from moderate-to-severe pain. The study is expected to enroll 200 adult patients rescued by Italian helicopter emergency medical services, … [Read more...] about Mundipharma initiates Phase 3 trial of Penthrox in trauma patients rescued from hostile environments

Breath Therapeutics has announced the initiation of Phase 3 studies of its L‑CsA‑i inhaled liposomal cyclosporine A for the treatment of bronchiolitis obliterans. Breath Therapeutics licensed L-CsA-i from PARI in 2017, and the drug is delivered via PARI's eFlow nebulizer. The 48-week BOSTON-1 and BOSTON-2 studies are each expected to enroll 110 lung transplant … [Read more...] about Breath Therapeutics initiates Phase 3 trials of nebulized liposomal cyclosporine A for bronchiolitis obliterans

Liquidia Technologies has announced that the Phase 3 INSPIRE study of its LIQ861 DPI in pulmonary arterial hypertension (“PAH”) patients met its primary endpoint. In January 2019, the company announced encouraging preliminary results from the study. According to Liquidia, the 2-month study, which enrolled 109 patients, demonstrated that doses of up to 150 mcg of … [Read more...] about Phase 3 trial of Liquidia’s inhaled treprostinil meets primary endpoint

Verona Pharma said that it plans to initiate the second phase of a two-part Phase 2 trial of its RPL554 ensifentrine DPI in COPD patients after the first part of the study demonstrated that the DPI produced significant improvement in FEV1. The company announced initiation of the study in December 2018. The Phase 2 study enrolled 37 moderate-to-severe COPD patients … [Read more...] about Verona announces positive interim data from Phase 2 study ensifentrine DPI