Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal spray (formerly LV-101) when it acquired Levo Therapeutics in June 2022 and announced plans to develop ACP-101 for hyperphagia in PWS … [Read more...] about Acadia announces initiation of Phase 3 trial of ACP-101 carbetocin nasal spray for hyperphagia in PWS
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1nhaler raises £2 million for development of its single-use cardboard DPI
Scottish device company 1nhaler has raised £2 million for development of a credit-card sized dry powder inhaler in a funding round led by Archangels, the investment firm announced. The 1nhaler device is made out of cardboard, contains a single dose of carrier-free API deposited on a membrane, and is breath-activated. According to the announcement, 1nhaler was … [Read more...] about 1nhaler raises £2 million for development of its single-use cardboard DPI
BiomX says it plans to move forward with development of BX004 inhaled phage cocktail based on data from second half of Phase 1b/2a trial
Based on results from Part 2 of the Phase 1b/2a trial, BiomX said that it plans to advance its BX004 nebulized phage cocktail for the treatment of chronic P. aeruginosa lung infections in cystic fibrosis patients into a Phase 2b/3 trial "subject to regulatory feedback and availability of sufficient funding." The study data demonstrated limited efficacy, with culture … [Read more...] about BiomX says it plans to move forward with development of BX004 inhaled phage cocktail based on data from second half of Phase 1b/2a trial
Qnovia reports results from Phase 1 trial of QN-01 inhaled nicotine replacement therapy
Qnovia (formerly Respira Technologies) has announced results from a Phase 1 trial of its QN-01 inhaled nicotine replacement therapy, which is based on the company's RespiRx vibrating mesh nebulizer platform. In September 2022, the company announced that it had raised $17 million for development of the nicotine replacement product. The Phase 1 PK study enrolled 12 … [Read more...] about Qnovia reports results from Phase 1 trial of QN-01 inhaled nicotine replacement therapy
Hovione partners with IDC on new intranasal dry powder delivery devices
CDMO Hovione has announced a partnership with Industrial Design Consultancy (IDC) for development of two new devices for intranasal delivery of dry powder formulations. According to the announcement, the capsule-based single-use and multidose devices will be available exclusively in conjunction with Hovione's nasal drug development and manufacturing services. … [Read more...] about Hovione partners with IDC on new intranasal dry powder delivery devices
FDA issues warning letter to Cipla citing significant problems at inhaler manufacturing facility, including continued production of defective MDIs
An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla's metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. Among the issues cited in the letter is a failure to respond adequately to more than 3,000 complaints received between April 2020 and December 2022 that reported … [Read more...] about FDA issues warning letter to Cipla citing significant problems at inhaler manufacturing facility, including continued production of defective MDIs
Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA
According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase 1 clinical trial of its ETH47 inhaled mRNA in healthy participants before the end of the year. The company is developing ETH47 as for the … [Read more...] about Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA
FDA accepts Orexo’s NDA for OX124 intranasal dry powder naloxone for the treatment of opioid overdose
Orexo said that the FDA has accepted the company's NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The company initially announced that it had submitted an NDA for OX124 in February 2023; however, the FDA rejected that application, requesting additional information about the … [Read more...] about FDA accepts Orexo’s NDA for OX124 intranasal dry powder naloxone for the treatment of opioid overdose
US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD
According to Seelos Therapeutics, the US Army Medical Research and Development Command will include the company's SLS-002 intranasal racemic ketamine in an adaptive platform trial of therapies for post-traumatic stress disorder (PTSD) in soldiers and veterans. The Phase 2 Department of Defense PTSD Adaptive Platform Trial (NCT05422612), which is expected to be … [Read more...] about US Army to evaluate Seelos’s SLS-002 intranasal racemic ketamine for the treatment of PTSD
Lupin launches Vilfuro-G triple combination DPI in India
Lupin announced that the Drug Controller General of India approved the company's Vilfuro-G vilanterol / fluticasone furoate / glycopyrronium bromide dry powder inhaler for the treatment of COPD, and the company has launched the DPI in India. Earlier this year, Lupin announced the launch of its Difizma indacaterol / glycopyrronium / mometasone DPI in India for the … [Read more...] about Lupin launches Vilfuro-G triple combination DPI in India