Johnson & Johnson said that it has submitted an sNDA to the FDA for the use of Spravato esketamine CIII nasal spray as a monotherapy for the treatment of treatment-resistant depression. In 2019, the FDA approved an NDA submitted by J&J subsidiary Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) for the use of Spravato with an oral … [Read more...] about J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression
Regulatory
FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
The FDA has issued a complete response letter to Orexo's NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose, the company said. Orexo resubmitted the NDA in September 2023 after the agency rejected its first application due to concerns about the packaging process. The NDA had been initially submitted in early 2023. The FDA accepted the … [Read more...] about FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company's NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1 (IDH1) mutation. NeOnc announced the initiation of the trial, which initially focused on treatment of grade 4 gliomas, in May 2016. The … [Read more...] about FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
CHMP recommends approval of ARS’s EURneffy adrenaline (epinephrine) nasal spray for anaphylaxis
ARS Pharmaceuticals announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company's MAA for the European version of its Neffy epinephrine nasal spray. In April 2024, ARS announced that it had submitted a Day 180 response regarding the MAA for the nasal spray to CHMP. If approved, the European … [Read more...] about CHMP recommends approval of ARS’s EURneffy adrenaline (epinephrine) nasal spray for anaphylaxis
Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
Tiziana Life Sciences announced that it will dose a patient with moderate Alzheimer’s disease with intranasal foralumab under an expanded access IND. The company previously used the expanded access program to provide intranasal foralumab to multiple sclerosis patients at Brigham and Women’s Hospital and for home use before initiating a Phase 2a trial of foralumab for … [Read more...] about Tiziana says the FDA has approved use of intranasal foralumab in Alzheimer’s patients under an expanded access IND
FDA approves Verona’s Ohtuvayre (nebulized ensifentrine) for the treatment of COPD
According to Verona Pharma, the FDA has approved the company's NDA for Ohtuvayre (ensifentrine, RPL554), a PDE3/PDE4 inhibitor delivered via jet nebulizer, for the treatment of COPD. Verona submitted the NDA for ensifentrine in June 2023, and the FDA accepted the NDA for review in September 2023. The company says that Ohtuvayre will be available to patients in the US … [Read more...] about FDA approves Verona’s Ohtuvayre (nebulized ensifentrine) for the treatment of COPD
MHRA approves Type II variation to the Voke nicotine inhaler marketing authorization
OBG subsidiary Ayrton Saunders announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a Type II variation to the 2014 marketing authorization for the Voke nicotine inhaler, which is approved for general sales as a nicotine replacement therapy. According to the Ayrtons web site, the company "has completely redeveloped the original … [Read more...] about MHRA approves Type II variation to the Voke nicotine inhaler marketing authorization
Agomab’s AGMB-447 inhaled ALK5 inhibitor gets orphan drug designation from the FDA
According to Agomab Therapeutics, the company's AGMB-447 inhaled ALK5 inhibitor has received orphan drug designation from the FDA for the treatment of idiopathic pulmonary fibrosis (IPF). Agomab initiated a Phase 1 trial of AGMB-447 in December 2023. Agomab Chief Medical Officer Philippe Wiesel commented, “Receiving orphan drug designation from the FDA provides … [Read more...] about Agomab’s AGMB-447 inhaled ALK5 inhibitor gets orphan drug designation from the FDA
Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
According to Liquidia Corporation, a judge in the US District Court for the District of Delaware has denied a United Therapeutics motion seeking a preliminary injunction to prevent Liquidia from launching Yutrepia treprostinil DPI for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Earlier this year, the company said that … [Read more...] about Judge denies United Therapeutics bid to block launch of Liquidia’s Yutrepia treprostinil DPI
FDA accepts Milestone’s NDA for Cardamyst etripamil nasal spray
Milestone Pharmaceuticals announced that the FDA has accepted the company’s NDA for Cardaymyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone originally submitted the NDA in October 2023, and the FDA issued a Refuse to File letter in December 2023. The company re-submitted the NDA in March 2024. Milestone … [Read more...] about FDA accepts Milestone’s NDA for Cardamyst etripamil nasal spray