Seelos Therapeutics asserts that the second part of its Phase 2 trial of SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in major depressive disorder would have met its primary endpoint if the study had been able to reach full enrollment. According to the company, the trial enrolled only 147 out of an anticipated 220 … [Read more...] about Seelos says 2nd part of Phase 2 study of SLS-002 intranasal racemic ketamine for suicidal ideation and behavior demonstrated improvement in symptoms
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ISAM Congress 2023
The International Society for Aerosols in Medicine (ISAM) welcomed more than 260 attendees to its 2023 biannual congress August 26-30 in Saarbrücken, Germany, reports organizing committee member Claus-Michael Lehr of the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS). In addition to the scientific program, the meeting included 6 workshops, 21 … [Read more...] about ISAM Congress 2023
ReCode Therapeutics announces additional funding for development of its inhaled mRNA therapies
ReCode Therapeutics announced that it has raised $50 million as an extension to a Series B financing, with funds going toward clinical development of its inhaled mRNA therapies for the treatment of primary ciliary dyskinesia and cystic fibrosis. The company says that it has now raised a total of $260 million in Series B funding. ReCode CEO Shehnaaz Suliman … [Read more...] about ReCode Therapeutics announces additional funding for development of its inhaled mRNA therapies
FDA issues CRL to ARS’ NDA for Neffy intranasal epinephrine for the treatment of allergic reactions
According to ARS Pharmaceuticals, the FDA has issued a complete response letter to the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis, and the agency has requested the completion of a PK/PD repeated-dose study prior to approval. The CRL also asked for more information on nitrosamine impurities, which the … [Read more...] about FDA issues CRL to ARS’ NDA for Neffy intranasal epinephrine for the treatment of allergic reactions
Virex gets almost A$500,000 grant for development of GlyXine inhaled antiviral
The Western Australian Future Health Research and Innovation Fund has awarded a A$499,241 Innovation Seed Fund grant to Virex Pharma for development of Glyxine, an inhaled antiviral nanoemulsion, for the treatment of respiratory syncytial virus. According to Virex, the grant will go toward testing of Glyxine in epithelial cells and in animal models of RSV at Wal-yan … [Read more...] about Virex gets almost A$500,000 grant for development of GlyXine inhaled antiviral
Virpax spins off Novvae Pharmaceuticals to develop AnQlar nasal spray
Virpax Pharmaceuticals announced that it has spun off a wholly-owned subsidiary called Novvae Pharmaceuticals that will develop Virpax's over-the-counter products, starting with AnQlar antiviral nasal spray. Virpax acquired North American rights to AnQlar, which contains a mucoadhesive polymer derived from chitosan, from Nanomerics in August 2020 and expanded the deal … [Read more...] about Virpax spins off Novvae Pharmaceuticals to develop AnQlar nasal spray
Orexo resubmits NDA for OX124 intranasal naloxone
Orexo announced that it has resubmitted an NDA for OX124 naloxone nasal powder for the reversal of opioid overdose. In February 2023, the company announced that it had submitted an NDA for OX124 and then in April announced that it would have to resubmit the application due to "unexpected technical issues with the equipment used for the secondary packaging process in … [Read more...] about Orexo resubmits NDA for OX124 intranasal naloxone
FDA issues final guidance on human factors principles for combination products
The FDA issued a document on September 8, 2023 titled "Application of Human Factors Engineering Principles for Combination Products: Questions and Answers," which is the final version of a draft guidance titled "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" that was issued in 2016. According to the … [Read more...] about FDA issues final guidance on human factors principles for combination products
Evoke Pharma gets notice of allowance for new US patent covering Gimoti metoclopramide nasal spray
According to Evoke Pharma, the company has received a notice of allowance from the US Patent and Trademark Office (USPTO) for patent application No. 17/366,829 ("Nasal Formulations of Metoclopramide"). The patent will cover the composition of Evoke's Gimoti intranasal metoclopramide, which was approved by the FDA in June 2020 for the treatment of diabetic … [Read more...] about Evoke Pharma gets notice of allowance for new US patent covering Gimoti metoclopramide nasal spray
NurExone says that it held pre-IND meeting with the FDA regarding ExoPTEN intranasal therapy for spinal cord injuries
NurExone Biologic announced that the company has received feedback from the FDA following a pre-IND meeting regarding NurExone's ExoPTEN intranasal exosome therapy and now plans to submit an IND by the end of this year with the goal of initiating Phase 1/2 clinical trials in 2025. In July 2022, the company said that it had contracted with Polyrizon for development of … [Read more...] about NurExone says that it held pre-IND meeting with the FDA regarding ExoPTEN intranasal therapy for spinal cord injuries