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news.The US food and Drug Administration (FDA) has granted approval for Spriaso's new drug application (NDA) for Tuxarin ER, a high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine.
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Jointly developed with Nexgen Pharma, Tuxarin ER will be the first product to provide long lasting cough suppression with a safer opiate that is less prone to respiratory distress while minimizing serious risk of dosing errors in patients aged 18 years and older.
The company said that Tuxarin ER, as a convenient solid unit dose form, is easy to dispense and overcomes disadvantages associated with acting liquids that are prone to spills and dosing errors.
Spriaso president and CEO Firoozeh Patel said: "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."
Chlorpheniramine is one of the most widely used anti-histamines for the management of cough and cold co-symptoms.
Recently, the long acting hydrocodone-chlorpheniramine product was reclassified as a DEA schedule II product thereby limiting patient access.