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Medical

Discovery Labs announces progress on inhaled therapies

Within the last week, Discovery Laboratories has announced that its aerosolized KL4 surfactant has received orphan drug designation from the EU for the treatment of cystic fibrosis, and it has presented data on a new product, Afectair, which it calls "a series of proprietary ventilator circuit/patient interface connectors and related componentry" that "simplifies the … [Read more...] about Discovery Labs announces progress on inhaled therapies

Positive Phase 3 results for ciclesonide nasal aerosol for perennial allergic rhinitis

Sunovion is presenting results from a 26-week double-blind, randomized Phase 3 study of ciclesonide HFA nasal aerosol involving more than 1,100 patients with perennial allergic rhinitis (PAR) that showed statistically significant improvement in nasal symptoms for ciclesonide compared to placebo. The study demonstrated positive results for both a 74 mcg dose and a 148 … [Read more...] about Positive Phase 3 results for ciclesonide nasal aerosol for perennial allergic rhinitis

Lightlake provides additional details on studies of nasal spray for eating disorders

Lightlake Therapeutics has provided additional details of recently announced Phase 2 trials of its naloxone nasal spray for binge eating disorder and for bulimia nervosa. Binge eating disorder trials have begun in Helsinki, with 138 patients randomly selected from more than 900 applicants taking either intranasal naloxone or a placebo nasal spray, says the … [Read more...] about Lightlake provides additional details on studies of nasal spray for eating disorders

Phase 3 results for Merck’s Dulera for the treatment of COPD

Merck has announced results of two Phase 3 clinical studies of Dulera mometasone furoate/formoterol fumarate inhalation aerosol for the treatment of COPD that show statistically significant improvement in lung function in most of the combinations studied and document the incidence of treatment-related adverse events for two dosage strengths. Dulera is approved in the … [Read more...] about Phase 3 results for Merck’s Dulera for the treatment of COPD

Insight recalls lot of Nostrilla nasal decongestant spray

Insight Pharmaceuticals has voluntarily recalled a single lot of its Nostrilla oxymetazoline hydrochloride nasal spray due to possible contamination with Burkholderia cepacia bacteria. Nostrilla is available without prescription, and lot #11G075, which consisted of 34,092 1/2-oz bottles, was distributed in US retail stores and pharmacies. According to Insight, it has … [Read more...] about Insight recalls lot of Nostrilla nasal decongestant spray

Acton publishes positive Phase 3b data for flunisolide inhaler

Acton Pharmaceuticals has published positive results from a Phase 3b clinical trial of its Aerospan flunisolide HFA metered dose inhaler in the October issue of Annals of Allergy, Asthma & Immunology. The article, titled, "Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled hydrofluoroalkane in prepubescent children with mild persistent … [Read more...] about Acton publishes positive Phase 3b data for flunisolide inhaler

Trimel concludes Phase 2 study of intranasal gel for female sexual dysfunction

Trimel Pharmaceuticals plans to present data from a recently completed Phase 2 "vibro-tactile stimulation (VTS) study" of its TBS-2 intranasal gel for the treatment of anorgasmia in women to the FDA at a meeting scheduled for November 2011. According to Trimel, in August 2011, it notified the CRO conducting the study that "patient enrolment would be considered … [Read more...] about Trimel concludes Phase 2 study of intranasal gel for female sexual dysfunction