Vernalis stopped cold: US FDA rejects cough medicine NDA

By Flora Southey contact

- Last updated on GMT

iStock/tibor13
iStock/tibor13
The US FDA has rejected Vernalis’ new drug application for its investigative cough and cold treatment CCP-08, which is the second time the firm has failed to win approval for a product this year.  

The company announced​ the receipt of a complete response letter (CRL) from the US Food and Drug Administration (FDA) on Monday, saying the same issues that blocked drug candidate CCP-07 in April, also hindered its CCP-08 application.

“Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08,” ​said CEO Ian Garland.

On April 21 the firm announced​ the FDA had issued a CRL rejecting its NDA for cough and cold drug candidate CCP-07.

At the time, the firm said “The CRL did not raise any concerns with the formulation of pharmacokinetic profile of CCP-07 but did identify outstanding items that need to be addressed prior to the resubmission and approval of the NDA.”

“The approval of both CCP-08 and most importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible,” ​said CEO Ian Garland.

The company said in its press release it would release updates on the progress of CCP-008 and CCP-07 in the coming months, but did not respond to a request for further information.

Extended-release technology

Both CCP-07 and CCP-08 are products of an exclusive licensing and collaboration agreement between Tris Pharma and Vernalis, which sees Tris developing up to six liquid, cough cold treatments for the US market.

Under the terms of the agreement, Vernalis obtains exclusive rights to Tris’ extended-release (ER) technology, and will own and commercialise all approved products.

Related topics: Regulatory & Safety, Regulations

Related news

Related product

Related suppliers