Friday, AP Pharma Inc. (APPA) announced that it has been issued a complete response letter by the FDA for its antiemetic drug APF530 for chemotherapy-induced nausea and vomiting. The decision date was on March 18 and in anticipation of the drug's approval, the stock rose 32% to $2.06 yesterday. In pre-market trading Friday, following the FDA rejection, the stock is down over 63% to $0.75.
In its complete response letter, the FDA has raised concerns relating to the company's two-syringe administration system and also has identified certain deficiencies in its manufacturing facilities. Satisfactory resolution of the deficiencies will be required for approval.
Though the FDA has asked for the re-presentation and re-analysis of select existing phase III clinical trial data, it has not requested additional clinical efficacy studies, the company said.
Since some of the FDA's points were addressed in recent NDA amendments by A.P. Pharma that the regulatory agency did not review prior to issuing the complete response letter, the company believes that the amendments may address some of the issues raised in the complete response letter.
Based on the anticipated time needed to prepare a resubmission, AP Pharma noted that it does not anticipate the commercial launch of APF530 this year.
A majority of patients receiving chemotherapy experience nausea and vomiting. Since CINV (chemotherapy-induced nausea and vomiting) can lead to patients discontinuing chemotherapy, prevention and control of CINV is important in the treatment of cancer patients.
Acute onset CINV occurs within the first 24 hours following chemotherapy treatment, while delayed onset CINV occurs more than 24 hours after treatment and may persist for several days. Based on the strength or degree to which chemotherapy treatments cause vomiting, or emesis, they can be classified as moderately emetogenic or highly emetogenic.
The current treatment options for CINV include 5-HT3 antagonists such as palonosetron (Eisai Co.'s Aloxi), ondansetron (GlaxoSmithKline plc's (GSK) Zofran), dolasetron (Sanofi-Aventis' (SNY) Anzemet) and granisetron (Roche's Kytril), as well as aprepitant (Merck & Co. Inc.'s (MRK) Emend), an NK1 antagonist, which is always used in combination with a 5-HT3 antagonist.
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