CyDex gets good results for combination solution nasal spray

CyDex Pharmaceuticals, in Kansas, US, says its Phase 2 clinical trials of novel, proprietary Captisol-enabled budesonide/azelastine nasal spray for seasonal allergic rhinitis (SAR) demonstrated statistically significant improved results over a nasal spray placebo.

The spray is being studied as a novel combination of two drugs used to treat seasonal allergic rhinitis: budesonide and azelastine. Budesonide has been used clinically for more than 20 years. Azelastine is an antihistamine currently marketed as Astelin nasal spray. Captisol, CyDex's patented sulfobutyl ether [beta]-cyclodextrin, enables the combination of the two drugs in an aqueous solution.

A randomised, double-blind, placebo-controlled, three-way cross-over study was conducted in 108 SAR patients to compare the relative efficacy of Captisol-enabled budesonide + azelastine nasal spray (single solution) and Rhinocort Aqua/ (suspension) + Astelin nasal spray (solution) against a placebo nasal spray solution in the treatment of allergic rhinitis in an environmental exposure chamber.

Relief of all nasal symptoms were said to be greater, onset of action of relief from itchy nose and sneezing were significantly faster and relief of all eye symptoms was significantly greater than a placebo. Captisol-enabled budesonide/azelastine provided the same or greater numerical TOSS relief than Rhinocort Aqua/Astelin and longer-lasting relief of red/burning eyes and itchy eyes.

Theron Odlaug, president and ceo of CyDex, said: Our ongoing r&d progress at CyDex, as demonstrated by this Phase 2 clinical trial, will continue to propel us forward as we grow to become a formidable specialty pharmaceutical company. The Captisol-enabled budesonide/ azelastine nasal spray product is one we intend to license to a commercial partner..

The company is planning a Phase 3 clinical trial with a development and commercialisation partner.

It is also licensing its Captisol technology and developing its own pipeline of products using its enabling technology solutions and partnering with pharma and biotechcompanies.