Verona Pharma has announced that a Phase 2b study of its RPL554 inhaled PDE3/PDE4 inhibitor met its primary endpoint, demonstrating significant improvement in FEV1 compared to placebo at 4 weeks in patients with moderate-to-severe COPD for all 4 doses tested. The study also met secondary endpoints, with significant improvements in 12-hour average FEV1, respiratory … [Read more...] about Verona reports positive Phase 2b results for RPL554
Medical
Intranasal ketamine trial halted due to side effects
According to an article published March 15, 2018 in the Journal of Psychopharmacology, a pilot trial of intranasal ketamine for the treatment of severe depression conducted by researchers from the University of New South Wales (UNSW) and the Black Dog Institute was suspended due to poor tolerability. The trial was halted after the first 5 patients dosed … [Read more...] about Intranasal ketamine trial halted due to side effects
Savara initiates Phase 2 study of Molgradex for NTM lung infections
Savara, which just announced the discontinuation of its Aironite development program after the failure of a Phase 2 trial to meet its endpoint, says that it has initiated a Phase 2a clinical study of Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection. … [Read more...] about Savara initiates Phase 2 study of Molgradex for NTM lung infections
Windtree and Eleison Pharmaceuticals partner on potential development of inhaled lipid cisplatin
Windtree Therapeutics and Eleison Pharmaceuticals will jointly evaluate the feasibility of delivering Eleison's inhaled lipid cisplatin (ILC) for the treatment of lung cancer via Windtree's proprietary pulmonary aerosol delivery system (ADS), the companies said. A formulation of ILC incorporating Windtree's KL4 surfactant will also be considered. Eleison, which has … [Read more...] about Windtree and Eleison Pharmaceuticals partner on potential development of inhaled lipid cisplatin
Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint
Savara has announced that the Phase 2 INDIE study of Aironite sodium nitrite inhalation solution for the treatment of heart failure with preserved ejection fraction (HFpEF) failed meet its primary endpoint and, as a result, the company is discontinuing development of the product. Mast Therapeutics acquired Aironite when it acquired Aires Pharmaceuticals in 2014; … [Read more...] about Savara discontinues development of Aironite after Phase 2 trial fails to meet primary endpoint
MannKind initiates Phase 1 trial of Treprostinil Technosphere DPI for PAH
MannKind Corporation has announced the initiation of a Phase 1 clinical study of its dry powder formulation of treprostinil based on its Technosphere inhaled delivery technology for the treatment of pulmonary arterial hypertension (PAH). The company said that the Treprostinil Technosphere (TreT) study is being conducted under an IND filed with the FDA in January. … [Read more...] about MannKind initiates Phase 1 trial of Treprostinil Technosphere DPI for PAH
Study shows improved cardiac function for COPD patients using Ultibro Breezhaler
Results from the CLAIM study published online in Lancet Respiratory Medicine on February 21, 2018 show that COPD patients using Novartis's Ultibro Breezhalerindacaterol/glycopyrronium DPI had significantly decreased lung hyperinflation and improved cardiac function after 14 days compared to placebo. Ultibro Breezhaler has been approved for the treatment of COPD in … [Read more...] about Study shows improved cardiac function for COPD patients using Ultibro Breezhaler
Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose
Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics' Intravail absorption enhancer, which Opiant licensed in 2017. … [Read more...] about Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose
Savara’s IND for Moldgradex study approved
According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in December 2017. The approval allows the company to enroll patients in the ongoing Phase 3 IMPALA study at sites in the … [Read more...] about Savara’s IND for Moldgradex study approved
Auris Medical announces pre-clinical and Phase 1 PK data for intranasal betahistine
Auris Medical Holding has announced that a PK study of an intranasal betahistine formulation demonstrated 5-35 times higher bioavailability in dogs compared to oral betahistine, and a Phase 1 study showed 20-40 times higher bioavailability for the intranasal formulation compared to oral betahistine in humans. The company is developing AM-125 intranasal betahistine … [Read more...] about Auris Medical announces pre-clinical and Phase 1 PK data for intranasal betahistine