According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in December 2016. Neurelis President and CEO Craig … [Read more...] about Neurelis submits NDA for Valtoco diazepam nasal spray
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Senzer reports data from PK study of inhaled dronabinol
According to Senzer, a PK study conducted by Insys Therapeutics found that a 0.35 mg dose of dronabinol delivered by Senzer's Voke inhaler achieved a similar maximum concentration as a 5.0 mg dose of Marinol oral dronabinol, with the inhaled dose reaching Cmax in 2 minutes compared to almost 2 hours for the oral dose. Insys acquired US rights to the Voke inhaler … [Read more...] about Senzer reports data from PK study of inhaled dronabinol
Phase 3 trial of intranasal esketamine fails to meet primary endpoint
Just weeks after Janssen announced that it had submitted an NDA for its intranasal esketamine for the treatment of depression, the company has presented data from a Phase 3 trial of the nasal spray that failed to meet its primary endpoint. Positive results from a previous Phase 3 study were published in May 2018. The new data from a study that enrolled 346 adults … [Read more...] about Phase 3 trial of intranasal esketamine fails to meet primary endpoint
CHMP issues positive opinion regarding expanded use of Trelegy Ellipta
According to GlaxoSmithKline and Innoviva, the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding wider use of the Trelegy Ellipta fluticasone furoate/umeclidinium/ vilanterol DPI in moderate-to-severe COPD. Trelegy Ellipta was approved in Europe in November 2017 for patients not adequately treated by an ICS and a … [Read more...] about CHMP issues positive opinion regarding expanded use of Trelegy Ellipta
Dance Biopharm raises $24.5 million for continued development of inhaled insulin
Dance Biopharm announced that the company completed a private equity financing round that raised $24.5 million that included participation by Molex Ventures, an electronics company that is involved in development of the Dance 501 connected soft mist inhaler for delivery of insulin. In December 2017, Dance announced that it had partnered with Phillips-Medisize for … [Read more...] about Dance Biopharm raises $24.5 million for continued development of inhaled insulin
Roivant launches new company to develop cromolyn inhalation solution
Roivant, which recently acquired Patara Pharma's cromolyn sodium inhalation solution for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), has launched a company called Respivant to develop the drug. The new company will be led by former Patara CEO Bill Gerhart. Gerhart has extensive experience in inhaled drug development; having … [Read more...] about Roivant launches new company to develop cromolyn inhalation solution
VistaGen licenses nasal spray for the treatment of social anxiety disorder
VistaGen Therapeutics has acquired exclusive global rights to PH94B aloradine nasal spray, which Pherin Pharmaceuticals has been developing for the treatment of social anxiety disorder (SAD), the company said. A Phase 3 study of PH94B for SAD is planned for the first half of 2019. Pherin received $2.25 million of unregistered common stock from VistaGen for the … [Read more...] about VistaGen licenses nasal spray for the treatment of social anxiety disorder
NDA for Inbrija inhaled levodopa gets new PDUFA date
Acorda Therapeutics has announced that the PDUFA date for review of its NDA for the Inbrija levodopa DPI for the treatment of symptoms during OFF periods in Parkinson's disease patients has been changed from October 5, 2018 to January 5, 2019. The company said that the FDA extended the review period because Acorda's submission in response to a request by the … [Read more...] about NDA for Inbrija inhaled levodopa gets new PDUFA date
FDA issues new draft guidance for albuterol sulfate DPIs
The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate. The guidance covers development of generic equivalents to Teva's ProAir RespiClick, which was approved for the treatment of asthma in adults in 2015 and for pediatric use in 2016. The draft … [Read more...] about FDA issues new draft guidance for albuterol sulfate DPIs
Mylan acquires TOBI products from Novartis
Mylan said that the company is paying approximately $463 million to Novartis for worldwide rights to TOBI Podhaler tobramycin DPI and TOBI tobramycin inhalation solution. Approximately $240 million of that amount will be paid in 2018. The company said that its acquisition of the products, which are approved in a number of countries for the treatment of P. … [Read more...] about Mylan acquires TOBI products from Novartis