Atai Life Sciences announced that it has initiated a Phase 1 proof-of-concept trial of its INB-01, an excipient designed to cause gelling of liquid nasal sprays when the aerosol deposits in the nasal cavity. In July 2021, Atai said that it was launching a company called Innaris Bio to develop the sol-gel technology for use in intranasal CNS drug formulations in … [Read more...] about Atai Life Sciences initiates Phase 1 trial of INB-01 intranasal gelling excipient
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Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint
According to Milestone Pharmaceuticals, the Phase 3 RAPID (formerly NODE 301b) trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint, demonstrating that almost two thirds of patients using etripamil converted to sinus rhythm within half an hour while less than a third of patients using a placebo … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint
Avalyn Pharma names Lyn Baranowski as CEO
Avalyn Pharma, which is developing its AP01 pirfenidone inhalation solution for the treatment of idiopathic pulmonary fibrosis (IPF), has named Lyn Baranowski as CEO, succeeding Bruce Montgomery. Baranowski was most recently Chief Operating Officer of Altavant Sciences and has extensive experience in commercial and business roles at pharmaceutical companies, including … [Read more...] about Avalyn Pharma names Lyn Baranowski as CEO
Transpire Bio announces development deal with INTO and names new Chief Scientific Officer
Transpire Bio, which previously announced deals with Recipharm for development of four inhaled products, announced a new deal with INTO (Inhalation Together) for development of three additional inhaled products: TRB-5, TRB-6 and TRB-7. INTO is a partnership between DFE Pharma, Sterling, and Harro Höfliger that was formed earlier this year to provide early development … [Read more...] about Transpire Bio announces development deal with INTO and names new Chief Scientific Officer
Odyssey Health creates subsidiary for development of intranasal drugs
Odyssey Health has announced the creation of a subsidiary called Odyssey Neuropharma that will develop intranasal drugs for the treatment of neurological disorders, including PRV-002 intranasal synthetic neurosteroid for the treatment of concussion. In addition to PRV-002, the company says that it intends to develop spray-dried dry powder nasal formulations for the … [Read more...] about Odyssey Health creates subsidiary for development of intranasal drugs
CoreRx adds particle engineering capabilities with Bend Bioscience deal
According to early stage CDMO Bend Bioscience, the company is now part of Florida-based CDMO CoreRx thanks to an equity investment by NovaQuest Private Equity, which acquired CoreRx in 2021. Bend Bioscience, which launched in 2021, will offer particle engineering and manufacturing services for a range of dosage forms, including dry powders for inhalation. Bend … [Read more...] about CoreRx adds particle engineering capabilities with Bend Bioscience deal
Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine
According to Orexo, a Phase 1 trial of OX640 nasal epinephrine powder demonstrated that each of 4 formulations evaluated was safe and well tolerated and achieved epinephrine plasma levels comparable to autoinjected intramuscular epinephrine (EpiPen). Each of the intranasal formulations also produced concentration-dependent changes in blood pressure and heart rate. The … [Read more...] about Positive Phase 1 results for Orexo’s OX640 intranasal epinephrine
Blue Water to develop its intranasal S. pneumoniae vaccine for the prevention of pneumococcal pneumonia
Blue Water Vaccines said that it intends to develop its BWV-201 intranasal Streptococcus pneumoniae vaccine candidate for the prevention of non-invasive pneumococcal pneumonia. The company is already developing the live attenuated intranasal vaccine, which it licensed from St. Jude Children’s Research Hospital, for the prevention of acute otitis media in children. … [Read more...] about Blue Water to develop its intranasal S. pneumoniae vaccine for the prevention of pneumococcal pneumonia
Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane
Australian cannabinoid developer Incannex Healthcare said that its pre-IND meeting with the FDA regarding its IHL-216A inhaled CBD/isoflurane for the treatment of traumatic brain injury was "constructive." In June 2021, Incannex signed an agreement with inhalation CDMO Vectura for preclinical development services for IHL-216A. The company said at that time that … [Read more...] about Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane
Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone
Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022, the company announced that it had received Fast Track designation for RiVive (HRT001) and had signed a commercial supply agreement. The company said that it is … [Read more...] about Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone