SALT LAKE CITY, Nov. 6, 2014 (GLOBE NEWSWIRE) -- Spriaso LLC. (www.spriasollc.com), today announced FDA acceptance of a New Drug Application (NDA) to seek approval for Rinotuss12®, a unique Rx cough/cold combination product containing codeine and chlorpheniramine. Rinotuss12®, co-developed with Nexgen Pharma, will be the first product to offer long lasting cough suppression with a safer opiate that is less prone to respiratory distress while minimizing serious risk of dosing errors. As a convenient solid unit dose form, Rinotuss12® is easy to dispense and overcomes messiness associated with short acting liquids that are prone to spills and dosing errors.
"If approved, this patient friendly combination product will be a significant advancement in safely managing cold symptoms. Rinotuss12 will be the only DEA schedule III long acting codeine combo with Chlorpheniramine, enabling better patient access at the pharmacy than the DEA schedule II combination alternatives," commented Firoozeh Patel, president and CEO of Spriaso LLC.
Cough is the most frequent illness requiring a doctor visit and accounted for about 33 million prescriptions for the 2013 cough/cold season. Of these, approximately 13 million were codeine based product prescriptions. Codeine is a safer narcotic antitussive that decreases the urge to cough by working in the brain to suppress the cough reflex.
The vast majority of patients with cough, cold & flu also have runny nose symptoms. Chlorpheniramine is one of the most widely used anti-histamines to manage cough and cold co-symptoms. Recently, the most popular long acting hydrocodone-chlorpheniramine product was reclassified as a DEA schedule II product thereby limiting patient access. Currently available codeine containing antitussive products are short acting, requiring four to six times a day dosing. Long acting Rinotuss12® should significantly improve patient compliance with twice a day dosing frequency.
About Spriaso LLC.
Spriaso is a privately funded specialty company that has several unique cough/cold products under development. Spriaso is actively seeking a marketing partner for its late stage products.