According to Meda, the FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. Meda filed the NDA approximately one year ago, in April 2011. Meda CEO Anders Lonner said, "Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work … [Read more...] about FDA approves Meda’s Dymista nasal spray, warns company on Astepro script
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Paper compares multi-component particles to mixed powders for inhaled combination therapies
A review paper published in the Spring 2012 issue of European Respiratory Disease contends that, "Drug delivery to lungs with a consistent and predesigned ratio of co-associated active components can help maximise the chance of co-location at the active site and hence increases the potential of synergistic action from the solid." Authored by Dipesh Parikh, David … [Read more...] about Paper compares multi-component particles to mixed powders for inhaled combination therapies
Upsher-Smith recruiting for Phase 3 study of midazolam nasal spray
Upsher-Smith Laboratories is recruiting patients aged 14-65 with partial or generalized epilepsy who experience seizure clusters for an ongoing Phase 3 clinical trial called ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray). As part of the recruiting effort, the company has launched a website, www.seizureclusterstudy.com. Upsher-Smith is … [Read more...] about Upsher-Smith recruiting for Phase 3 study of midazolam nasal spray
Positive Phase 2 topline results for ISTA’s Beposone nasal spray
ISTA Pharmaceuticals has announced results from a Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of its Beposone bepotastine besilate/steroid nasal spray for the treatment of seasonal allergic rhinitis. According to the company, the study showed that Beposone produced statistically significant improvements in nasal symptoms of … [Read more...] about Positive Phase 2 topline results for ISTA’s Beposone nasal spray
Asmanex Twisthaler shortage
The FDA issued a drug shortage alert for the Asmanex Twisthaler 110 mcg mometasone furoate inhalation Powder, 30 inhalation units, as of April 26, 2012. According to the FDA web site, the shortage is due to manufacturing delays and the expected duration is unknown. The 110 mcg dose Asmanex Twisthaler is recommended for the treatment of asthma in children ages 4-11 … [Read more...] about Asmanex Twisthaler shortage
Team Consulting introduces new API-only dry powder inhaler technology
Team Consulting is introducing its new Occoris inhaler engine technology designed specifically for the delivery of API-only formulations for systemic therapies. The flexible Occoris system offers repeatable delivery of a wide range of dose sizes with no carrier necessary, Team says, facilitating pulmonary delivery of vaccines, analgesics, insulin, and other … [Read more...] about Team Consulting introduces new API-only dry powder inhaler technology
Aptar launches new capsule-based inhaler
Aptar Pharma has announced the launch of the Twister capsule-based dry powder inhaler. The new DPI is intended to provide a cost-effective dry powder alternative to metered dose inhalers (MDIs), especially in the third world, the company says, with the aim of permitting "a wider range of asthma sufferers to not only gain better access to medication but also become … [Read more...] about Aptar launches new capsule-based inhaler
Pharmaxis gets marketing authorization for bronchitol in Europe
The European Commission has granted marketing authorization to Pharmaxis for its Bronchitol mannitol inhalation powder for the treatment of cystic fibrosis in patients 18 and over. In October 2011, the CHMP adopted a positive opinion regarding approval of the drug after several prior negative opinions. The company will officially launch the product in Europe at … [Read more...] about Pharmaxis gets marketing authorization for bronchitol in Europe
Savara’s AeroVanc inhaled vancomycin well tolerated in Phase 1a study
Savara Pharmaceuticals has announced top-line data from a Phase 1a study of its AeroVanc vancomycin hydrochloride inhalation powder for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients. According to the company, the study, which compared single ascending doses of AeroVanc with intravenous vancomycin in healthy … [Read more...] about Savara’s AeroVanc inhaled vancomycin well tolerated in Phase 1a study
SKBP licenses diazepam nasal spray to Hanmi
SK Biopharmaceuticals has licensed its diazepam nasal spray for an undisclosed amount to Seoul, Korea-based Hanmi Pharmaceuticals, giving Hanmi marketing rights for China and Korea. Hanmi expects to launch the nasal spray in Korea in 2013 and in China in 2015. In the US, SKBP licensed the product to Neuronex, which was acquired by Accorda earlier this year. SKBP … [Read more...] about SKBP licenses diazepam nasal spray to Hanmi