Acorda Therapeutics presented data from a Phase 1 study of its diazepam nasal spray at the American Academy of Neurology Annual Meeting this week showing that the plasma bioavailability of a 20 mg dose of diazepam nasal spray was comparable to that of a 20 mg dose of diazepam rectal gel. The company acquired the product, which is being developed for the treatment of … [Read more...] about Acorda Phase 1 data shows diazepam nasal spray has comparable biovailability to rectal gel
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Additional funding for Savara’s AeroVanc
Savara Pharmaceuticals has received additional funding for Phase 2 development of its AeroVanc vancomycin inhalation powder for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients. The company brought its Series B financing to a total of $16 million after closing a $7.4 million second tranche and has also received … [Read more...] about Additional funding for Savara’s AeroVanc
Upsher Smith presents positive Phase 1 data for intranasal midazolam
Upsher Smith presented positive Phase 1 data for its USL261 intranasal midazolam at the American Academy of Neurology (AAN) Meeting this week. The company launched a website to recruit patients for a Phase 3 study of the product last year. The intranasal formulation is being developed for the rescue treatment of seizures in epilepsy patients and is "intended to … [Read more...] about Upsher Smith presents positive Phase 1 data for intranasal midazolam
Pharmaxis gets complete response letter for Bronchitol
According to Pharmaxis, the FDA has issued a complete response letter regarding its Bronchitol inhaled mannitol for the treatment of cystic fibrosis. The company says that the FDA requested another clinical trial. The Pharmaxis press release quotes the CRL, which says, “The submitted data do not provide a favorable benefit‐risk balance to support the use of inhaled … [Read more...] about Pharmaxis gets complete response letter for Bronchitol
Mylan levalbuterol inhalation solution ANDA approved
According to Mylan, its subsidiary Mylan Specialty L.P. has received FDA approval for its Abbreviated New Drug Application (ANDA) for levalbuterol inhalation solution, a generic version of Sunovion's Xopenex inhalation solution. The product is used for the treatment of bronchospasm caused by asthma and COPD. Mylan says that it has begun shipping product. Sunovion … [Read more...] about Mylan levalbuterol inhalation solution ANDA approved
Pearl Therapeutics wins Drug Delivery Partnerships Innovation Award
Pearl Therapeutics was awarded the 2013 Drug Delivery Partnerships (DDP) Innovation Award for its co-suspension formulation technology, according to the company. The company is developing several metered dose inhalation products using the technology. President and CEO Chuck Bramlage said, “We truly appreciate this award by our peers in the drug delivery industry. … [Read more...] about Pearl Therapeutics wins Drug Delivery Partnerships Innovation Award
Alexza hires Peter Schineller as Senior VP and Chief Commercial Officer
Alexza Pharmaceuticals has hired Peter W. Schineller as its new Senior VP and Chief Commercial Officer, responsible for global commercialization of the company's Adasuve Staccato inhaled loxapine. The FDA approved Adasuve for the treatment of agitation in patients with schizophrenia or bipolar I disorder in December 2012. In Europe, the product was approved in … [Read more...] about Alexza hires Peter Schineller as Senior VP and Chief Commercial Officer
University of East Anglia to team with Procarta on anti-MRSA nasal spray
The University of East Anglia (UEA) Medical School will fund research to adapt a MRSA-specific antibiotic being developed by Procarta Biosystems into a nasal spray for decolonization of patients before major surgery, according to Procarta. The company says that use of the spray against methicillin-resistant Staphylococcus aureus (MRSA) infections "promises to speed … [Read more...] about University of East Anglia to team with Procarta on anti-MRSA nasal spray
FDA panel votes against calcitonin nasal spray
In a joint meeting of the FDA's Advisory Committee for Reproductive Health Drugs (ACRHD) and the Drug Safety and Risk Management Advisory Committee (DSaRM), panelists voted 12-9 that the risk of cancer from calcitonin outweigh its potential benefits for osteoporosis. The panel also voted 20-1 that developers of new calcitonin products would have to prove efficacy in … [Read more...] about FDA panel votes against calcitonin nasal spray
PADAC meeting on Breo Ellipta postponed
The March 7 meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) for discussion of the Breo Ellipta inhaler, has been postponed due to weather. As of March 6, the meeting on GSK's application for the fluticasone furoate/vilanterol dry powder inhaler has not been rescheduled. Read the meeting announcement. … [Read more...] about PADAC meeting on Breo Ellipta postponed