Firebrick Pharma announced that it has filed a Pediatric Investigation Plan (PIP) with the EMA's Pediatric committee for its Nasodine povidone-iodine nasal spray as the company plans to submit a marketing application for Nasodine by the end of 2023. In April 2022, Firebrick initiated a Phase 2 study of Nasodine for the treatment of COVID-19. A Phase 3 trial of … [Read more...] about Firebrick Pharma files Pediatric Investigation Plan for Nasodine povidone-iodine nasal spray
Regulatory
Optinose submits sNDA for Xhance fluticasone propionate nasal spray to treat chronic sinusitus
Optinose announced that it has submitted an sNDA for a label expansion of Xhance fluticasone propionate nasal spray (OPN-375) for the treatment of chronic sinusitis without nasal polyps. Xhance has been approved for the treatment of nasal polyps in the US since 2017. In June 2022, the company announced that the second of two Phase 3 trials of Xhance for the treatment … [Read more...] about Optinose submits sNDA for Xhance fluticasone propionate nasal spray to treat chronic sinusitus
Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
Beckley Psytech said that the FDA has approved the company's IND for a Phase 2b study comparing 2 doses of BPL–003 intranasal dry powder synthetic 5-MeO-DMT (mebufotenin) in patients with treatment-resistant depression. According to Beckley Psytech, the proposed Phase 2b study, which is expected to be initiated in the first half of this year, is the first ever … [Read more...] about Beckley Psytech gets go-ahead for Phase 2b study of BPL-003 intranasal synthetic 5-MeO-DMT
FDA advisory committee recommends approval of Narcan naloxone nasal spray for OTC sales
The FDA's Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have voted unanimously in favor of over-the-counter use of Narcan naloxone nasal spray for the reversal of opioid overdose. In December 2022, the FDA accepted Emergent BioSolutions' sNDA for OTC sales of Narcan for priority review, with a PDUFA goal … [Read more...] about FDA advisory committee recommends approval of Narcan naloxone nasal spray for OTC sales
Orexo submits NDA for OX124 intranasal naloxone
Orexo announced that it has submitted an NDA for its OX124 intranasal naloxone for the reversal of opioid overdose. The company notes that FDA review is likely to take a little more than a year and says that it is planning for a launch in the first half of 2024. OX124 is based on the company's amorphOX particle engineering technology, which also underlies its … [Read more...] about Orexo submits NDA for OX124 intranasal naloxone
FDA accepts Opiant’s NDA for OPNT003 intranasal nalmefene
According to Opiant Pharmaceuticals, the FDA has accepted the company's NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose for priority review and has set a PDUFA date of May 22, 2023. In October 2022, Opiant announced that it had completed its rolling submission of the NDA for OPNT003. The company has received funding from the … [Read more...] about FDA accepts Opiant’s NDA for OPNT003 intranasal nalmefene
Vero Biotech closes $30 million financing to support commercialization of Genosyl tankless iNO system
Vero Biotech announced an investment of $30 million from Petrichor Healthcare Capital Management that will be used for commercialization of Vero's Genosyl DS tankless inhaled nitric oxide system. The company recently announced that it had received FDA approval for the third generation Genosyl DS for delivery of iNO to increase oxygenation in newborn infants with … [Read more...] about Vero Biotech closes $30 million financing to support commercialization of Genosyl tankless iNO system
Cyrano announces plans for Phase 2 trial of CYR-064 intranasal theophylline in patients with post-viral hyposmia
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
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