Source : Strategic Pharmaceuticals Company LLC
Researchers from Strategic BioSciences, together with investigators from the Institute for Asthma and Allergy (Wheaton, MD) reported that the new all-natural product is safe and effective in relieving symptoms of allergic rhinitis. MucoAd® is a mucoadhesive molecule (hypromellose) that prolongs contact with the nasal surface so that the nasal spray is well tolerated, lasts longer, and repeat dosing is needed less frequently.
The double-blind cross-over study included 24 patients suffering from symptomatic, persistent allergic rhinitis who recorded the severity of their runny nose, itchy nose, stuffy nose and sneezing twice a day for a month. The capsaicin- MucoAd® formula (Sinol-M™) was compared to the 1st generation product without MucoAd® (Sinol™). Capsaicin nasal spray reduced all symptoms, and symptom relief was achieved with less Sinol-M than Sinol – particularly at night, suggesting that Sinol-M might permit a better night’s sleep, free from rhinitis symptoms. There were no treatment related adverse events during the study and Sinol-M was associated with less subjective reports of discomfort.
“This study represents the first-ever capsaicin-based treatment for allergic rhinitis to be supported by prospective clinical data, and has important implications for millions of Americans who suffer from nasal allergies. This all-natural product has now been demonstrated to provide clinical effectiveness without any of the side effects associated with intra-nasal steroids and is available without a prescription. It may also provide a new option for patients looking for a zinc-free, all-natural product in the wake of the June 16, 2009 Food and Drug Administration (FDA) warning to consumers to stop using and discard zinc-containing intranasal products (Zicam), due to numerous reports that they may cause a loss of sense of smell (anosmia). ” commented Dr. Michael A. Kaliner, of the Institute of Asthma and Allergy, Wheaton, Maryland, and principal author and presenter of this poster.
Full results of the study will be published in a peer reviewed journal.
Sinol™ is registered as a homeopathic product in the US. Its principal active ingredient is capsaicin, which is derived from the hot pepper plant. The 2nd generation formulation, Sinol-M™, adds a patented mucoadhesive solution (MucoAd®) that prolongs the contact between a drug and the mucosa. Sinol-M™ is now available in the US and Canada.
Nasal allergies affect approximately 20% of the US population or about 50 million people, including 10%-30% of adults and up to 40% of children. The American Academy of Allergy, Asthma and Immunology (AAAAI) estimates that seasonal allergies cause over 8.2 million days of restricted activity, 3.8 million lost school and work days and 16.7 million medical office visits. Absenteeism and reduced productivity due to allergic rhinitis, specifically, is estimated, to cost US companies and the health care system more than $6 billion per year.
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