Medical

Satsuma Pharmaceuticals, which was spun out from SNBL in 2017 specifically for the purpose of developing STS 101 intranasal dihydroergotamine (DHE) for the treatment of migraine, said that a Phase 1 clinical trial demonstrated that STS101 was well tolerated, with none of the typical side effects of injected DHE such as nausea and vomiting. STS101 was rapidly absorbed … [Read more...] about Satsuma announces Phase 1 results, plans for Phase 3 trial of its intranasal DHE for the treatment of migraine

FluGen has announced that preliminary data from a Phase 2 trial show that its intranasal M2SR manufactured with a strain of influenza that was used in vaccines during the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season. Demonstrating protection against the highly mismatched virus is a "major step toward … [Read more...] about Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus

Biohaven Pharmaceutical announced the successful completion of a Phase 1 trial of its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist and said that the company plans to initiate a Phase 2 efficacy trial in the second quarter of 2019. Biohaven CEO Vlad Coric said, "We are excited to report that intranasal administration of BHV-3500 in … [Read more...] about Biohaven announces plans for Phase 2 trial of BHV-3500 intranasal migraine drug

Novus Therapeutics has provided an update on ongoing Phase 1 clinical trials of its OP0201 nasal MDI for the treatment of otitis media and has announced plans for a Phase 2a study in infants and children. The new randomized, double-blind, placebo-controlled Phase 2a trial (C-006), which replaces a planned Phase 1 study in children with otitis media with effusion, … [Read more...] about Novus Therapeutics announces Phase 2a study of OP0201 intranasal MDI for otitis media

According to Verona Pharma, the World Health Organization (WHO) has approved the name “ensifentrine” as the international non-proprietary name for the company’s RPL554 inhaled PDE3/PDE4 inhibitor, which is in development as both an MDI and a DPI for the treatment of respiratory diseases. Verona Pharma CEO Anders Karlsson said, “We are pleased to receive approval … [Read more...] about Verona Pharma’s RPL554 gets international non-proprietary name “ensifentrine”

Insys Therapeutics said that a dose finding study of its epinephrine nasal spray that enrolled 49 healthy volunteers demonstrated that one of two doses of the nasal spray tested had a PK profile comparable to the PK profiles of EpiPen (0.3 mg) and Adrenalin (0.5 mg). In June 2018, the company reported results from a proof of concept PK study that showed similar … [Read more...] about Insys announces results from PK study of its epinephrine nasal spray

Liquidia Technologies has announced interim data from the Phase 3 INSPIRE trial of its LIQ861 DPI treprostinil for the treatment of pulmonary arterial hypertension demonstrating that LIQ861 was well-tolerated at doses of up to about 125 μg in PAH patients after two weeks, a safety endpoint requested by the FDA. The company announced initiation of the study in January … [Read more...] about Liquidia announces interim results from Phase 3 INSPIRE trial of inhaled treprostinil

Orexo has announced results from a PK study of its OX124 naloxone nasal spray in 20 healthy volunteers that compared 4 development formulations of OX124 to Narcan naloxone nasal spray. According to the company, all 4 formulations of OX124 demonstrated "substantially higher" plasma concentrations of naloxone compared to Narcan, with equal or faster onset times. The … [Read more...] about Positive Phase 1 results for Orexo’s intranasal naloxone