Nevada-based Corstasis Therapeutics announced that the FDA has accepted the company's NDA for RSQ-777 bumetanide nasal spray, a diuretic for the treatment of edema associated with congestive heart failure, kidney disease, and liver disease. The agency assigned a PDUFA target date of September 14, 2025. Corstasis CEO Benjamin Esque commented, “We are pleased … [Read more...] about Corstasis says that the FDA has accepted its NDA for RSQ-777 bumetanide nasal spray for the treatment of edema
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Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial
North Carolina-based Belhaven Biopharma announced that it has closed a funding round that raised $11 million for continued development of the company's Nasdepi intranasal dry powder epinephrine for the treatment of anaphylaxis. The company said that the funds will support the completion of clinical development and preparations for an NDA submission. Belhaven also … [Read more...] about Belhaven Biopharma raises $11 million for development of Nasdepi intranasal dry powder epinephrine, initiates clinical trial
KAER Bio launches AeroPulsR high dose delivery system for critical care use
KAER Biotherapeutics has announced the launch of the AeroPulsR aerosol device for delivery of high doses of aqueous aerosols in critical care settings. According to KAER, the AeroPulsR can deliver liquids of viscosities up to 50 cP as aerosols with particle sizes in the 2-4 μm range. The device also can deliver aerosols in continuous, periodic, or spontaneous … [Read more...] about KAER Bio launches AeroPulsR high dose delivery system for critical care use
Vast Therapeutics gets ~$2 million NIH grant for development of ALX1 inhalation solution for the treatment of P. aeruginosa lung infections
Vast Therapeutics announced that the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has awarded the company $1,988,594 to support a 2-year project titled "Nebulized ALX1 as a treatment for Pseudomonas aeruginosa infections in bronchiectasis patients." According to the company's web site, "ALX1 contains a water … [Read more...] about Vast Therapeutics gets ~$2 million NIH grant for development of ALX1 inhalation solution for the treatment of P. aeruginosa lung infections
FDA approves J&J’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of depression
According to Johnson & Johnson, the FDA has approved the company's sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of major depressive disorder in adults who have not responded adequately to a minimum of two oral antidepressants. Administration of Spravato is available only in healthcare settings under a REMS program. Spravato has … [Read more...] about FDA approves J&J’s sNDA for Spravato esketamine nasal spray as a monotherapy for the treatment of depression
Newbury’s azelastine / fluticasone nasal spray approved in Norway
Swedish pharma company Newbury Pharmaceuticals announced that its marketing application for Azelastine + Fluticasone Newbury, a generic version of Dymista azelastine / fluticasone nasal spray, has been approved by Norwegian regulators for the treatment of allergic rhinitis. The company said that it has also submitted marketing applications in Sweden, Finland, and … [Read more...] about Newbury’s azelastine / fluticasone nasal spray approved in Norway
Nemera and Nipro announce compatibility of Nemera’s UniSpray nasal pump and Nipro’s unit dose vials
Nemera and Nipro Pharma Packaging have announced the conclusion of compatibility testing of Nemera’s UniSpray nasal pump with Nipro’s unit dose "microvials." According to the companies, the tests demonstrated complete compatibility and meet requirements for reliability and dose delivery. Nemera announced the launch of the UniSpray single metered dose nasal pump, … [Read more...] about Nemera and Nipro announce compatibility of Nemera’s UniSpray nasal pump and Nipro’s unit dose vials
Emergent BioSolutions acquires US and Canadian rights to Hikma’s Kloxxado naloxone nasal spray
Emergent BioSolutions announced that it has signed an agreement to acquire marketing rights to Hikma Pharmaceuticals’ Kloxxado naloxone nasal spray in the US and Canada. Kloxxado, which delivers an 8 mg dose, was approved by the FDA for the reversal of opioid overdose in September 2021. Emergent previously acquired Narcan nasal spray, which delivers a 4 mg dose of … [Read more...] about Emergent BioSolutions acquires US and Canadian rights to Hikma’s Kloxxado naloxone nasal spray
Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray
Vistagen has announced the initiation of a Phase 2 repeat dose study of fasedienol nasal spray, which the company is developing for the treatment of social anxiety disorder. The Phase 3 PALISADE-3 and PALISADE-4 trials of fasendiol for that indication are ongoing. According to Vistagen, the design of the Phase 2 repeat dose trial is basically the same as the … [Read more...] about Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray
Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis
Orexo has announced topline results from its OX640-002 PK/PD study of OX640 intranasal dry powder epinephrine in people with allergic rhinitis. According to the company, the study, which was initiated in October 2024, demonstrated that absorption of OX640 occurred significantly faster in subjects with allergic rhinitis symptoms than in those without rhinitis symptoms. … [Read more...] about Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis