Cadence Pharmaceuticals Inc. (CADX) recently announced that it intends to re-submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its intravenous painkiller Ofirmev (acetaminophen) within the next 30 days. Cadence is seeking approval to market the drug to treat pain and fever in adults and children.
 
In February 2010, the US agency issued a complete response letter to the company in response to the NDA filed for the approval of Ofirmev. The agency indicated in the letter that deficiencies were found at Cadence’s third party manufacturing facility during the FDA’s facility inspection.
 
Earlier in the month, Cadence met the US regulatory body and its third party manufacturer regarding the shortcomings highlighted in the complete response letter. The meeting, classified as a Type A meeting, is usually reserved for dispute resolution, discussing clinical holds and special protocol assessment (SPA) following the receipt of the FDA’s assessment letter.
 
The FDA did not ask for any additional information related to the NDA. Furthermore, the agency did not ask Cadence to conduct additional studies. This is encouraging news as additional studies would have delayed approval significantly.
 
The agency will determine whether this re-submission will be treated as a class I or class II review. Depending on the classification, a decision from the FDA should be out 2-6 months after the response is submitted.
 
Ofirmev is Cadence Pharmaceuticals’ proprietary intravenous formulation of acetaminophen. Acetaminophen is the most prevalent therapy for treating pain and fever in the US. It is available in more than 600 combination and single-ingredient prescription and over-the-counter products.
 
The exclusive rights to Ofirmev in the US and Canada were acquired by Cadence in 2006 from Bristol-Myers Squibb (BMY) in 2006. The drug is marketed by Bristol-Myers as Perfalgan in Europe and other parts of the world. IV acetaminophen is approved in approximately 80 countries globally, including major European markets, where it is the market leader among all injectable analgesics.
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