After receiving a "Study May Proceed" letter from the FDA, Vistagen has announced plans for a Phase 1 trial of a re-formulated version of PH10 pherin nasal spray. The new Phase 1 study is expected to begin in early 2023 as part of plans to develop the nasal spray for the treatment of major depressive disorder. A previous Phase 2a trial of PH10 for that indication … [Read more...] about Vistagen announces planned Phase 1 trial of new formulation of PH10 nasal spray
Business
Nuance Pharma takes steps towards marketing Bentrio nasal spray in Hong Kong and Macau
Nuance Pharma has announced a deal with DKSH Business Unit Healthcare for commercialization of Bentrio, an API-free, bentonite-based OTC nasal spray for protection against allergens and viruses, in Hong Kong and Macau. Bentrio is currently marketed in several countries in Europe for allergic rhinitis, and in the US, the nasal spray received 510(k) clearance in June … [Read more...] about Nuance Pharma takes steps towards marketing Bentrio nasal spray in Hong Kong and Macau
Hyloris announces plans to develop an intranasal TRPV1 agonist for the treatment of idiopathic rhinitis
Belgium-based Hyloris Pharmaceuticals announced that it has added an intranasal TRPV1 agonist (HY-083) for the treatment of idiopathic rhinitis to its pipeline. TRPV1 (transient receptor potential cation channel subfamily V member 1) is overexpressed in the nasal mucosa in idiopathic rhinitis. According to the company, "Hyloris’ treatment approach is to activate and … [Read more...] about Hyloris announces plans to develop an intranasal TRPV1 agonist for the treatment of idiopathic rhinitis
Kindeva Drug Delivery to merge with Meridian Medical Technologies
CDMO Kindeva Drug Delivery, which specializes in inhalation, intradermal, and transdermal drug delivery, has announced that it will merge with fellow Altaris Capital Partners company Meridian Medical Technologies, which specializes in autoinjectors. Altaris acquired Kindeva (formerly 3M Drug Delivery Systems) from 3M in 2020 and acquired Meridian from Pfizer in 2021. … [Read more...] about Kindeva Drug Delivery to merge with Meridian Medical Technologies
Relief Therapeutics gets exclusive rights to aviptadil in settlement with NRx Pharmaceuticals
Relief Therapeutics and NRx Pharmaceuticals (formerly NeuroRx) said that they have settled litigation that originated with a dispute over payment for a clinical trial of nebulized aviptadil (RLF-100) for the treatment of COVID-19. According to the companies, Relief will take possession of all NRx assets related to aviptadil, "including its regulatory filings, patent … [Read more...] about Relief Therapeutics gets exclusive rights to aviptadil in settlement with NRx Pharmaceuticals
Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
Following the failure of the Phase 3 SUMMIT trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine to meet the study's primary endpoints, Satsuma Pharmaceuticals says that the company will not invest in commercialization of the product. In September 2020, the company announced that the Phase 3 EMERGE trial of STS101 failed to meet its … [Read more...] about Phase 3 trial of Satsuma’s STS101 DHE nasal powder for migraine fails to meet primary endpoints
Indivior to acquire Opiant Pharmaceuticals
Narcan naloxone nasal spray developer Opiant Pharmaceuticals has agreed to be acquired by Indivior for $20 per share at closing, plus up to $8 contingent value rights (CVRs) per share based on achievement of revenue goals for Opiant's OPNT003 intranasal nalmefene over a 7-year period, the company said. Both boards of directors have approved the deal, and the … [Read more...] about Indivior to acquire Opiant Pharmaceuticals
Court finds Symbicort patent invalid in win for Viatris and Kindeva
According to Viatris, the US District Court for the Northern District of West Virginia has determined that US Patent No. 10,166,247, which covers AstraZeneca's Symbicort budesonide / formoterol MDI, is invalid. In March 2021, the same court upheld claims in three other patents protecting Symbicort. An appeals court reversed the March 2021 decision in December 2021 and … [Read more...] about Court finds Symbicort patent invalid in win for Viatris and Kindeva
Viatris to acquire Oyster Point Pharma
Tyrvaya varenicline nasal spray maker Oyster Point Pharma announced that its board of directors has approved the company's plans to be acquired by Viatris for $11 per share at closing plus up to $2 per share if Oyster Point achieves certain performance goals for 2022. The FDA approved Tyrvaya for the treatment of dry eye disease in October 2021. Oyster Point is also … [Read more...] about Viatris to acquire Oyster Point Pharma
TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
TFF Pharmaceuticals announced that it has been working with Aptar Pharma on a project to develop dry powder vaccines based on TFF's thin film freezing particle manufacturing platform and Aptar Pharma’s Unidose (UDS) nasal powder delivery device. According to the company, Aptar Pharma presented data from the project at the recent Vaccines Summit 2022 and will present … [Read more...] about TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device