According to the FDA's latest update on the ongoing acetylcysteine inhalation solution shortage, all of American Regent/Luitpold's product is still on back order due to "manufacturing delays," and the company is still unable to estimate a release date for any inhalation solution. The company's Shirley, NY facility was shut down in April 2011 over safety concerns. … [Read more...] about Latest update on acetylcysteine inhalation solution shortage
Medical
Positive Phase 2b results for Pearl Therapeutics MDI
A randomized, double-blind, Phase 2b dose-ranging study of Pearl Therapeutics' formoterol fumarate MDI compared to Foradil Aerolizer and placebo showed statistically significant benefits in patients with moderate-to-severe COPD, according to the company. The metered dose inhaler product, known as PT005, demonstrated comparable improvements in lung function compared to … [Read more...] about Positive Phase 2b results for Pearl Therapeutics MDI
Study finds OTC capsaicin nasal spray effective for rhinitis
A randomized, double-blind study conducted by researchers from the University of Cincinnati has shown that a capsaicin nasal spray available over the counter significantly relieved nasal congestion, sinus pain, sinus pressure, and headache in patients with non-allergic rhinitis compared to placebo. The article appears in the August 2011 edition of Annals of Allergy, … [Read more...] about Study finds OTC capsaicin nasal spray effective for rhinitis
Phase 2 study of nasal spray for binge eating disorder to begin
British biopharmaceutical company Lightlake Therapeutics has announced that it will begin Phase 2 trials of its naloxone nasal spray for the treatment of binge eating disorder in overweight and obese patients on August 26th, 2011 in Helsinki, Finland. Naloxone is an opioid antagonist, and the nasal spray targets the endorphins produced when people eat foods high in … [Read more...] about Phase 2 study of nasal spray for binge eating disorder to begin
“Pressurized olfactory device” study shows improved opioid delivery
A study by University of Washington researchers published in the September 2011 issue of Anesthesia & Analgesia, the official journal of the International Anesthesia Research Society, demonstrates improved delivery of morphine and fentanyl in rats via a "pressurized olfactory device" (POD) compared to conventional nasal administration. The researchers are also … [Read more...] about “Pressurized olfactory device” study shows improved opioid delivery
Positive Phase 2 results for Verona bronchodilator for asthma
Verona Pharma has successfully completed a Phase 2 study of the duration of bronchodilator action by its lead drug RPL554 in patients with mild asthma, according to the company. RPL554 is a novel long-acting phosphodiesterase 3 and phosphodiesterase 4 enzyme inhibitor intended for intranasal administration, though the company has discussed MDI and DPI formulations, … [Read more...] about Positive Phase 2 results for Verona bronchodilator for asthma
FDA approves mometasone nasal implant for chronic sinusitis
The FDA has approved a pre-market approval (PMA) application from Intersect ENT for its Propel mometasone furoate drug delivery implant for the treatment of chronic sinusitis. The dissolvable device is inserted in the sinus cavity during surgery and maintains the opening of the ethnoid sinus while it delivers the corticosteroid to the sinus lining. David W. … [Read more...] about FDA approves mometasone nasal implant for chronic sinusitis
NexBio reports clinical trial results for inhaled antiviral
NexBio, which was recently raided by the US Federal Bureau of Investigation (FBI), has announced results from a Phase 2 clinical trial of its Fludase inhaled antiviral for the treatment of influenza. According to the company, the dry powder formulation, also known as DAS181, demonstrated a significant reduction of viral load in patients infected with influenza. The … [Read more...] about NexBio reports clinical trial results for inhaled antiviral
MannKind and FDA agree on design of new inhaled insulin trials
After a meeting with the FDA, MannKind Corporation has announced that the company and the agency have confirmed protocols for new efficacy and safety studies of Afrezza inhaled insulin. The original studies of Afrezza were conducted with MedTone inhaler, and in May, the FDA asked MannKind to conduct new trials with the new Dreamboat inhaler in patients with type 1 … [Read more...] about MannKind and FDA agree on design of new inhaled insulin trials
MHRA issues warning on Ubertan nasal spray
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers against using a "fake tan nasal spray" marketed as Ubertan. According to the agency, the product comes in two versions, one of which contains "melanotan II, an unlicensed medicine with no evidence of safety, quality or that it works, and with unknown side effects" and another that … [Read more...] about MHRA issues warning on Ubertan nasal spray