Civitas Therapeutics has initiated a 28-day Phase 2b efficacy and safety study of CVT-301 inhaled levodopa for the treatment of intermittent motor fluctuations in Parkinson's patients, the company said. The study is partially funded by a $1 million grant from the Michael J. Fox Foundation for Parkinson's Research. Civitas announced positive results from a Phase 2a … [Read more...] about Civitas initiates Phase 2B study of CVT-301 inhaled levodopa
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Study finds tiotropium Respimat safety comparable to tiotropium HandiHaler safety
A study appearing online first in the New England Journal of Medicine finds that "Tiotropium Respimat at a dose of 5 μg or 2.5 μg had a safety profile and exacerbation efficacy similar to those of tiotropium HandiHaler at a dose of 18 μg in patients with COPD." According to the authors, the TIOSPIR randomized, double-blind, parallel-group trial of more than 17,000 … [Read more...] about Study finds tiotropium Respimat safety comparable to tiotropium HandiHaler safety
Meda to acquire Acton Pharmaceuticals
Swedish pharmaceutical company Meda has agreed to acquire Massachusetts-based Acton Pharmaceuticals for $135 million plus a $10 million milestone payment and royalty milestones. According to Acton, the deal could be worth up to $200 million. Acton's products include the Aerospan flunisolide metered dose inhaler for the treatment of asthma, which was approved by the … [Read more...] about Meda to acquire Acton Pharmaceuticals
Hi-Tech Pharmacal to be acquired by Akorn
Opthalmic and injectables manufacturer Akorn will acquire Hi-Tech Pharmacal for $640 million in cash, the companies said. Hi-Tech Pharmacal's products include generic albuterol inhalation solution and fluticasone nasal spray, plus several OTC intranasal products. The company also offers contract manufacturing for a variety of dosage forms including inhalation … [Read more...] about Hi-Tech Pharmacal to be acquired by Akorn
Trinity College and Woolcock Institute get grant for collaboration
The Respiratory Technology Team of the Woolcock Institute for Medical Research (WIMR) has announced that a $12,000 International Research Collaboration Award from the University of Sydney will fund a collaboration between the team and Carsten Ehrhardt of Trinity College Dublin. Ehrhardt will perform research on drug absorption of inhaled drugs at WIMR during a … [Read more...] about Trinity College and Woolcock Institute get grant for collaboration
Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
Rigel Pharmaceuticals' R343 inhaled SYK inhibitor has failed to meet primary or secondary endpoints in a Phase 2 study, the company said. As a result, Rigel will discontinue development of the product for the treatment of asthma. The company announced the launch of a Phase 2 study called SITAR ((SYK Inhibition for Treatment of Asthma with R343) in September … [Read more...] about Inhaled SYK inhibitor fails to meet endpoints in Phase 2 study
Lightlake Therapeutics announces collaboration with the National Institute on Drug Abuse
Lightlake Therapeutics has announced that the US National Institute on Drug Abuse (NIDA) wiill sponsor a Phase 1 pharmacokinetic study of Lightlake's intranasal naloxone. If the results of the study are positive, the company said, NIDA will file an IND for further studies, with the goal of an FDA approval for intranasal naloxone for the reversal of opioid overdose … [Read more...] about Lightlake Therapeutics announces collaboration with the National Institute on Drug Abuse
NDA filing for aclidinium bromide/formoterol DPI delayed
Forest Laboratories and Almirall have announced that a planned 4th quarter 2013 NDA submission for their aclidinium bromide/formoterol dry powder inhaler will be delayed due to the need to address FDA concerns regarding chemistry, manufacturing and control (CMC) specifications. The companies said that they "are working with the FDA regarding the CMC related comments … [Read more...] about NDA filing for aclidinium bromide/formoterol DPI delayed
MannKind announces positive results from Phase 3 study of Afrezza
MannKind Corporation has announced that preliminary results from two Phase 3 clinical studies of Afrezza inhaled insulin met their primary endpoints. In a study in patients with Type 1 diabetes comparing Afrezza to insulin aspart, Afrezza was shown to be non-inferior in A1c level decreases and showed significant reductions in fasting blood glucose and significantly … [Read more...] about MannKind announces positive results from Phase 3 study of Afrezza
Aegis gets third patent for intranasal triptan formulations
Aegis Therapeutics has announced that it has received New Zealand Patent No. 5937828 for fast acting formulations of triptans that can be administered as nasal, buccal, or sublingual sprays. The company's Intravail formulations have been shown to reach therapeutic levels in the blood 20 to 30 times faster than currently marketed triptan tablets and nasal sprays. … [Read more...] about Aegis gets third patent for intranasal triptan formulations