Insys Therapeutics has announced the initiation of a Phase 1 proof-of-concept study to determine whether an epinephrine nasal spray for the treatment of anaphylaxis is bioequivalent to intramuscular injection of epinephrine. The trial will compare both aqueous and hydro-alcoholic formulations of intranasal epinephrine to EpiPen. The study, which is expected to … [Read more...] about Insys initiates Phase 1 study of intranasal epinephrine
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Mucodel announces positive results for study of intranasal naloxone
Mucodel Pharma has announced that a PK study of its intranasal naloxone met its endpoints and showed that the formulation based on its Co-Gel technology delivered the dose of naloxone faster than both an intranasal spray and intramuscular injection. in February 2017, the Mucodel filed a citizen petition with the FDA challenging the the safety of intranasal … [Read more...] about Mucodel announces positive results for study of intranasal naloxone
Acorda resubmits NDA for Inbrija L-Dopa DPI
Acorda Therapeutics said that it has resubmitted an NDA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson's disease patients. The company originally submitted the 505(b)(2) application in June 2017, and the FDA issued a refuse to file letter in response in August 2017. According to Acorda, the resubmitted application addresses two issues … [Read more...] about Acorda resubmits NDA for Inbrija L-Dopa DPI
Aerogen and Lyomark Pharma partner on nasally-inhaled surfactant for RDS
Aerogen Pharma and Lyomark Pharma have announced a partnership for development and commercialization of AP-002, a nasally-inhaled surfactant based on Lyomark's Alveofact bovine lung surfactant for the treatment of respiratory distress syndrome (RDS) in pre-term infants. According to Aerogen, the company has also initiated a Phase 2 study of AP-002 in Australia, with … [Read more...] about Aerogen and Lyomark Pharma partner on nasally-inhaled surfactant for RDS
Lonhala Magnair glycopyrrolate inhalation solution (formerly SUN-101/eFlow) approved by the FDA
Sunovion's NDA for Lonhala Magnair glycopyrrolate inhalation solution (formerly known as SUN-101/eFlow) has been approved by the FDA for the treatment of COPD, the company said. A US launch is planned in early 2018. In April 2016, Sunovion announced that the Phase 3 GOLDEN-3 and GOLDEN-4 studies had met their primary endpoints. The company's initial NDA for the … [Read more...] about Lonhala Magnair glycopyrrolate inhalation solution (formerly SUN-101/eFlow) approved by the FDA
Phillips-Medisize to develop connected device for Dance Biopharm’s inhaled insulin
Dance Biopharm announced that it has signed an agreement with Phillips-Medisize for development of a connected version of Dance's Dance 501 insulin soft mist inhaler device. According to the announcement, Phillips-Medisize has already worked on clinical devices for Dance 501, and the new agreement extends their work to potential commercial manufacture. Dance has … [Read more...] about Phillips-Medisize to develop connected device for Dance Biopharm’s inhaled insulin
Glenmark’s generic fluticasone/salmeterol DPI approved in Nordic countries
Glenmark Pharmaceuticals Europe said that its marketing authorization application for a generic version of Seretide Accuhaler (Advair Diskus) for the treatment of asthma and COPD has been approved through the decentralized procedure in the Nordic region, making the fluticasone/salmeterol DPI the company's first inhaled product approved by European authorities. In … [Read more...] about Glenmark’s generic fluticasone/salmeterol DPI approved in Nordic countries
FDA advisory committee schedules review of Linhaliq NDA
Aradigm has announced that the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) will meet on January 11, 2018 to review the NDA for Linhaliq inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients. Linhaliq is a mix of liposome-encapsulated and unencapsulated ciprofloxacin. The company submitted … [Read more...] about FDA advisory committee schedules review of Linhaliq NDA
Airware Labs agrees to acquire cannabis company for development of intranasal THC
Airware Labs Corporation has entered into a non-binding letter of intent to acquire a cannabis consulting company and grower doing business as Item 9 Labs with the goal of developing an intranasal THC product, Airware Labs Corp said. The agreement would be terminated if the two companies are unable to finalize terms by the end of the year. All of the products … [Read more...] about Airware Labs agrees to acquire cannabis company for development of intranasal THC
Savara gets $5 million from CFFT for AeroVanc development
Savara has received a development award of up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT), which will support the Phase 3 AVAIL study of the AeroVanc DPI for the treatment of MRSA lung infections in cystic fibrosis patients, the company said. In 2013, CFFT awarded the company $1.7 million for Phase 2 development of AeroVanc. Savara announced … [Read more...] about Savara gets $5 million from CFFT for AeroVanc development