Adamis Pharmaceuticals has announced that data from a Phase 1 PK study its APC-5000 fluticasone/salmeterol DPI, a generic carrier-free version of Advair Diskus, show less systemic exposure to both components compared to Advair. The open-label study compared 3 inhalations of APC-5000 to 3 inhalations of Advair Diskus in 16 healthy subjects over 4 treatment … [Read more...] about Adamis announces positive Phase 1 results for its fluticasone/salmeterol DPI
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Insmed confirms filing of MAA for Arikayce, announces new hires
In its announcement of fourth quarter and full year financial results for 2014, Insmed has confirmed that it filed an MAA for Arikayce liposomal amikacin inhalation solution. The company said that the EMA's Pediatric Committee has approved the Pediatric Investigation Plan for the product, and the MAA has subsequently been validated. Insmed also announced the … [Read more...] about Insmed confirms filing of MAA for Arikayce, announces new hires
TGA warns of smoking devices that look nearly identical to MDIs
Australia's Therapeutic Goods Administration (TGA) has issued a warning about devices marketed by a company called Discreet Vape that look nearly identical to metered dose inhalers used for rescue medications for asthma. The PUFFiT and PUFFiT-X devices are advertised as "the discreet choice" for smoking "dry herbal blends." Discreet Vape, based in Hong Kong, … [Read more...] about TGA warns of smoking devices that look nearly identical to MDIs
Newly launched Turing Pharmaceuticals to develop intranasal ketamine, Syntocinon
Several months after Retrophin announced that it would divest several of its pipeline products, including Syntocinon intranasal oxytocin and intranasal ketamine, to Turing Pharmaceuticals, the latter company has officially announced its launch. Turing Pharmaceuticals is headed by Martin Shkreli, who left Retrophin suddenly after reports of "stock trading … [Read more...] about Newly launched Turing Pharmaceuticals to develop intranasal ketamine, Syntocinon
Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution
A Phase 3 trial program of Sunovion Pharmaceutical's SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD has begun enrolling patients, the company announced. The program includes three studies expected to enroll about 2,340 COPD patients. SUN-101 is delivered using PARI's eFlow nebulizer system and, if approved, would be the … [Read more...] about Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution
Sales of Zomig nasal spray up in 2014
Prescriptions for Zomig nasal spray increased 23% in 2014 compared to 2013, Impax Laboratories said, helping to offset a major decrease in revenues for the Impax Pharmaceuticals division after the 2013 loss of exclusivity for Zomig tablets. Revenues dropped from $113.2 million in 2013 to $47 million for 2014. In the fourth quarter of 2014, increased sales of Zomig … [Read more...] about Sales of Zomig nasal spray up in 2014
Boehringer Ingelheim presents data from Phase 3 trials of tiotropium Respimat
Boehringer Ingelheim has presented data from five Phase 3 trials of tiotropium Respimat for the treatment of asthma at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The data come from two PrimoTinA-asthma trials (severe asthma), two MezzoTinA-asthma trials (moderate asthma), and a single GraziaTinA-asthma trial (mild asthma). … [Read more...] about Boehringer Ingelheim presents data from Phase 3 trials of tiotropium Respimat
Positive Phase 2 results for Savara’s AeroVanc
Savara Pharmaceuticals has announced positive results from a Phase 2 trial of its AeroVanc vancomycin DPI for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. In the 28-day trial, patients treated with AeroVanc had a statistically significant reduction in MRSA density in sputum compared to patients … [Read more...] about Positive Phase 2 results for Savara’s AeroVanc
Meda’s Dymista gets FDA approval for children aged 6-11
The FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis in children aged 6-11 "who require treatment with both components," the company said. Dymista was approved for adults and for children 12 and older in 2012. Meda submitted data from two pediatric trials to support the … [Read more...] about Meda’s Dymista gets FDA approval for children aged 6-11
Aegis Therapeutics gets patent for intranasal formulations
Aegis Therapeutics has announced that the US Patent and Trademark Office has awarded the company US Patent No. 8,927,497, which covers a method "for non-invasive delivery of anti-seizure drugs via a simple metered nasal spray" based on the company's Intravail transmucosal absorption enhancement technology. The patent, titled "Absorption enhancers for intranasal … [Read more...] about Aegis Therapeutics gets patent for intranasal formulations