Seelos Therapeutics said that it has initiated a Phase 1 study comparing PK profiles of SLS-002 intranasal racemic ketamine in Japanese and non-Asian adults. In May 2021, the company announced positive Phase 2 results for SLS-002 for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The intranasal ketamine is delivered … [Read more...] about Seelos Therapeutics initiates Phase 1 ethnobridging study of SLS-002 intranasal racemic ketamine
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Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Pulmatrix has announced the initiation of a Phase 2b trial of its PUR1900 dry powder itraconazole in patients with allergic bronchopulmonary aspergillosis (ABPA) and asthma. In 2020, PUR1900 received fast track designation for that indication. Pulmatrix is partnered with Cipla subsidiary Cip Tec on development of the itraconazole DPI, which it has previously called … [Read more...] about Pulmatrix initiates Phase 2b trial of PUR1900 itraconazole DPI in patients with ABPA and asthma
Orexo submits NDA for OX124 intranasal naloxone
Orexo announced that it has submitted an NDA for its OX124 intranasal naloxone for the reversal of opioid overdose. The company notes that FDA review is likely to take a little more than a year and says that it is planning for a launch in the first half of 2024. OX124 is based on the company's amorphOX particle engineering technology, which also underlies its … [Read more...] about Orexo submits NDA for OX124 intranasal naloxone
PTAB again supports Liquidia, denies United Therapeutics rehearing request for Tyvaso patent
According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has denied a request by United Therapeutics to revisit the board's July 2022 determination that none of the claims in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are patentable. Liquidia said that it expects United Therapeutics to appeal the denial of the rehearing to the US Court … [Read more...] about PTAB again supports Liquidia, denies United Therapeutics rehearing request for Tyvaso patent
Optinose names Ramy Mahmoud as CEO
Intranasal drug developer Optinose has announced the appointment of Ramy Mahmoud as CEO, succeeding Peter Miller. Mahmoud has served as Optinose's President and Chief Operating Officer since 2010; before joining the company, he served in a number of roles at Johnson & Johnson, including Chief Medical Officer. The company also announced that it expects to submit … [Read more...] about Optinose names Ramy Mahmoud as CEO
Aptar Pharma launches APF Futurity metal-free nasal spray pump for OTC products
Aptar Pharma announced that it has launched a metal-free multidose nasal spray pump called APF Futurity for delivery of over-the-counter formulations. According to Aptar Pharma, APF Futurity is designed to be recyclable without removing the pump from a container bottle and has received Class AA certification from cyclos-HT. Aptar Product Sustainability Director … [Read more...] about Aptar Pharma launches APF Futurity metal-free nasal spray pump for OTC products
Berry to open new manufacturing facility in Bangalore, India
Device manufacturer Berry Global says that it intends to hire 500 employees over 8 years to staff its new manufacturing facility in Bangalore, India, which will produce a variety of products, including nasal and inhaled drug delivery devices. The company had announced plans for the site in August 2021. Berry says that the Bangalore site has received International … [Read more...] about Berry to open new manufacturing facility in Bangalore, India
Bharat Biotech launches iNCOVACC intranasal COVID-19 vaccine in India
Bharat Biotech has announced the launch of its iNCOVACC (BBV154) intranasal COVID vaccine in India for use as both primary series and booster. In September 2022, India's Central Drugs Standard Control Organization (CDSCO) approved the use of iNCOVACC in adults aged 18 and older. iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine that Bharat … [Read more...] about Bharat Biotech launches iNCOVACC intranasal COVID-19 vaccine in India
Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
Vistagen has announced the initiation of a Phase 1 clinical trial of its PH10 pherine nasal spray, which the company is developing for the treatment of major depressive disorder. In November 2022, the company announced that it had gotten the go-ahead for the Phase 1 trial of a new formulation of PH10 from the FDA, and the agency granted Fast Track designation to PH10 … [Read more...] about Vistagen initiates Phase 1 trial of PH10 pherine nasal spray
MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study
MannKind Corporation said that it will advance MNKD-101 clofazimine to a Phase 2/3 study following positive results from a Phase 1 trial of the inhalation suspension delivered via jet nebulizer. The FDA has granted both orphan drug and QIDP designation to MNKD-101 for the treatment of nontuberculous mycobacterial (NTM) lung infections. The company also announced the … [Read more...] about MannKind says it will advance MNKD-101 clofazimine inhalation suspension to Phase 2/3 study