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FDA Approves Tuxarin ER

Spriaso Announces FDA Approval of Long Acting Tuxarin ER (codeine and chlorpheniramine)

SALT LAKE CITY, July 1, 2015 (GLOBE NEWSWIRE) -- Spriaso LLC today announced FDA approval of a New Drug Application (NDA) for Tuxarin ER, a unique high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine. Tuxarin ER, 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 in patients 18 years and older. As a convenient solid unit dose form, Tuxarin ER is easy to dispense and overcomes disadvantages associated with acting liquids that are prone to spills and dosing errors.

"Approval of this patient friendly combination product is expected to be a significant advancement in safely managing cough and cold symptoms. Tuxarin ER will be the only high strength, DEA non-schedule II long acting narcotic antitussive combo with chlorpheniramine. This will enable better patient access at the pharmacy versus that of the DEA schedule II combination alternatives," commented Firoozeh Patel, president and CEO of Spriaso LLC.

Cough associated with allergies and cold symptoms are one of the most common reasons for physician visits, 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 Tuxarin ER 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 approved Tuxarin ER, a long acting codeine antitussive with popular anti-histamine, chlorpheniramine.

About Nexgen Pharma

Nexgen Pharma is a privately held specialty pharmaceutical company that provides development and manufacturing services for Rx, OTC drugs as well as custom dietary supplement formulations. Nexgen Pharma has over 80 years of manufacturing experience with a rigorous commitment to quality and customer service.

Source: Spriaso LLC

Posted: July 2015

Tuxarin ER (chlorpheniramine and codeine) FDA Approval History

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