Cyrano Therapeutics said that the FDA has cleared the company's IND and that Cyrano now plans to move ahead with a Phase trial of CYR-064 nasal soft mist theophylline in patients who experienced hyposmia (loss of smell) following a viral infection. In December 2020, Cyrano announced that it had raised $12.8 million for a Phase 2 trial of CYR-064. The six-month trial … [Read more...] about Cyrano announces plans for Phase 2 trial of CYR-064 intranasal theophylline in patients with post-viral hyposmia
Regulatory
Krystal Biotech’s KB407 inhaled gene therapy for CF gets EC orphan designation
According to Krystal Biotech, the European Commission has granted orphan designation to the company's KB407 inhaled gene therapy for the treatment of cystic fibrosis. The company said that KB407, which delivers two copies of the CFTR gene to the lungs via nebulization, also has received Orphan Drug designation from the FDA. In August 2022, Krystal announced plans … [Read more...] about Krystal Biotech’s KB407 inhaled gene therapy for CF gets EC orphan designation
FDA approves Avillion and AstraZeneca’s Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma
According to Avillion and AstraZeneca, the FDA has approved Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma in adults. Avillion partnered with AstraZeneca subsidiary Pearl Therapeutics on development of PT027 in 2018. In May 2022, the FDA accepted Avillion's NDA for Airsupra. The NDA sought approval for the inhaler's use as an asthma therapy by … [Read more...] about FDA approves Avillion and AstraZeneca’s Airsupra (PT027) albuterol / budesonide MDI for the treatment of asthma
FDA approves Polarean’s inhaled hyperpolarized contrast agent for lung ventilation imaging
According to Polarean Imaging, the FDA has approved the company's NDA for its Xenoview inhaled xenon-129 gas blend, a hyperpolarized contrast agent for MRI imaging of lung ventilation. Xenoview is approved for use in patients aged 12 and over. The agency also cleared two Polarean 510(k)s, one for a chest coil "intended to be worn by a patient who inhales … [Read more...] about FDA approves Polarean’s inhaled hyperpolarized contrast agent for lung ventilation imaging
FDA accepts Harm Reduction’s NDA for RiVive intranasal naloxone and grants Priority Review designation
According to Harm Reduction Therapeutics, the FDA has accepted the company's NDA for its RiVive naloxone nasal spray for the reversal of opioid overdose and granted the NDA Priority Review designation. Harm Reduction had announced the initiation of a rolling NDA submission for RiVive in October 2022. The company says that the FDA has set April 28, 2023 as the goal … [Read more...] about FDA accepts Harm Reduction’s NDA for RiVive intranasal naloxone and grants Priority Review designation
Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
According to Virpax Pharmaceuticals, the FDA has provided guidance in response to the company's pre-Investigational New Drug NobrXiol (VRP324) CBD nasal powder, which Virpax is developing for the for the treatment of epilepsy. In September 2021, Virpax announced that it had acquired exclusive worldwide rights to Nanomerics’s molecular envelope technology (MET) for use … [Read more...] about Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Vertex Pharmaceuticals said that it plans to initiate a Phase 1 SAD trial of its VX-522 inhaled mRNA therapy after the FDA cleared the company's IND. VX-522 contains lipid nanoparticle-encapsulated mRNA that is designed to treat cystic fibrosis in patients who do not produce cystic fibrosis transmembrane conductance regulator (CFTR) and are therefore not helped by a … [Read more...] about FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
FDA accepts Emergent Biosolutions sNDA for OTC Narcan naloxone nasal spray
According to Emergent BioSolutions, the FDA has accepted the company's supplemental NDA for over-the-counter (OTC) sales of Narcan naloxone nasal spray for the reversal of opioid overdose and has set a PDUFA goal date of March 29, 2023. The sNDA is for a 4mg dose of Narcan, which is the original strength. In 2017, the FDA also approved a 2 mg dose, which has since … [Read more...] about FDA accepts Emergent Biosolutions sNDA for OTC Narcan naloxone nasal spray
Vistagen’s PH10 nasal spray gets Fast Track designation
The FDA has awarded Fast Track designation to Vistagen's PH10 pherin nasal spray for the treatment of major depressive disorder, the company said. Vistagen recently announced its plans for a Phase 1 trial of a re-formulated version of PH10 expected to begin in early 2023 after receiving a "Study May Proceed" letter from the agency. Vistagen CEO Shawn Singh said, … [Read more...] about Vistagen’s PH10 nasal spray gets Fast Track designation
FDA approves Aucta’s generic formoterol fumarate inhalation solution
The FDA has approved Aucta Pharmaceuticals' ANDA for its formoterol fumarate inhalation solution, a generic version of Mylan's Perforomist. Aucta's is the 4th Perforomist equivalent approved since the expiration of Mylan's final patent covering the inhalation solution. Teva launched its generic equivalent in the US in June 2021, and the FDA approved Alembic … [Read more...] about FDA approves Aucta’s generic formoterol fumarate inhalation solution