MAP Pharmaceuticals has announced that it has a meeting scheduled with the FDA during the second quarter of this year to discuss the complete response letter it received for its Levadex inhaled dihydroergotamine application. MAP President and CEO Timothy S. Nelson said, "We are pleased that the FDA has scheduled a meeting with us to discuss the issues contained in the … [Read more...] about MAP gets new patent for Levadex, schedules meeting with FDA
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US company introduces OTC horseradish nasal spray
Over-the-counter drug manufacturer GSC Products has introduced a horseradish nasal spray marketed as "Sinus Plumber." The company also developed a capsaicin nasal spray called Sinus Buster that was acquired by Hi-Tech Pharmacal earlier this year and a caffeinated nasal spray called Turbo Snort. Sinus Plumber, which the company is marketing as a cure for allergy … [Read more...] about US company introduces OTC horseradish nasal spray
SkyePharma announces second inhaler study with Respivert
SkyePharma has signed an agreement with RespiVert for a feasibility study to develop an inhaled dry powder formulation for a RespiVert compound, the second DPI project that the two companies have worked on together. Both projects involve the devlopment of inhaled drugs for the treatment of COPD and asthma. SkyePharma CEO Peter Grant commented, “We are pleased that … [Read more...] about SkyePharma announces second inhaler study with Respivert
Winston gets grant for development of nasal spray for trigeminal neuralgia
The National Institutes of Health (NIH) has awarded Winston Pharmaceuticals a $375,000 Small Business Innovation Research (SBIR) grant to support Phase 1 development of its civamide nasal spray for the treatment of postherpetic neuralgia (PHN) of the trigeminal nerve (TN). Civamide is a proprietary TRPV-1 receptor modulator that previously received orphan drug … [Read more...] about Winston gets grant for development of nasal spray for trigeminal neuralgia
Positive Phase 1 results for dry powder intranasal zolmitriptan
Shin Nippon Biomedical Laboratories has announced results from a Phase 1 study of its intranasal zolmitriptan formulation (TRZ) for the treatment of migraine headaches. The company is developing several intranasal drugs based on its μco muco-adhesive powder carrier system and intranasal powder delivery device. According to SNBL, the study, which compared three … [Read more...] about Positive Phase 1 results for dry powder intranasal zolmitriptan
Merck issues statement on Nasonex patent trial
Merck has issued a statement saying that the company "firmly believes its patent for Nasonex nasal spray is valid and infringed and will vigorously defend its intellectual property rights in a bench trial against Apotex Inc. and Apotex Corp. that began in US federal court today." Merck is suing Apotex for infringing U.S. Patent No. 6,127,353, issued to Schering in … [Read more...] about Merck issues statement on Nasonex patent trial
Copley introducing new breath simulator
Copley Scientific will be introducing its new BRS 3000 breath simulator for the testing of metered dose inhalers (MDIs) and dry powder inhalers (DPIs) at RDD 2012. The company previously introduced its BRS 2000 breath simulator for nebulisers at ISAM 2011. According to the company, "The BRS 3000 allows users to precisely define and apply breathing profiles that mimic … [Read more...] about Copley introducing new breath simulator
Two inhalers finalists in the Medical Design Excellence Awards
Two dry powder inhalers have been named as finalists in the 2012 Medical Design Excellence Awards sponsored by Medical Device and Diagnostic Industry. Sun Pharmaceutical's Combitide Starhaler and Novartis's TOBI Podhaler with Pulmosphere technology are both nominated in the "General Hospital Devices and Therapetic Products" category. Cambridge Consultants received … [Read more...] about Two inhalers finalists in the Medical Design Excellence Awards
Pearl Therapeutics creates nanogram-dose MDIs
According to Pearl Therapeutics, the company has produced metered dose inhalers (MDI) with the ability to deliver a 300ng dose of glycopyrrolate (GP) per actuation. Pearl formulated the GP for the nanogram-dose inhalers using the company's porous particle cosuspension technology and has initiated a Phase 2b study to evaluate safety and efficacy of twice a day dosing … [Read more...] about Pearl Therapeutics creates nanogram-dose MDIs
British Pharmacopoeial Commission requests comment on changes to inhaled product monographs
The British Pharmacopoeial Commission is requesting comment from OINDP manufacturers regarding proposed changes to its inhaled product monographs. The BP has posted a draft document authored by its Inhaled Products Working Party and has asked that manufacturers of MDIs, DPIs, and nebulizer solutions submit comments along with any relevant data. The draft document … [Read more...] about British Pharmacopoeial Commission requests comment on changes to inhaled product monographs