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Potentially $300MM+ Up for Grabs With Zofran’s QT Prolongation Safety Issues


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-Commonly Prescribed 32 mg Zofran Dose Banned-

-APF530 Patient Satisfaction Comparable to Aloxi-


Report is Available for Download at: www.lifesciadvisors.com/clients/ap

The FDA issued a drug safety communication for Zofran (ondansetron), the most prescribed generic 5-HT3 antagonist, stating that treatment leads to QT prolongation and the 32 mg single infusion dose is now banned. With this note, we highlight the negative impact that this safety issue should have on Zofran sales and the corresponding new opportunity that A.P. Pharma’s (OTC BB: APPA.OB) long-acting CINV drug, APF530, addresses, if approved.

Friday, June 29, the FDA issued a serious follow-up safety communication for Zofran following initial results from GlaxoSmithKline’s (“GSK,” NYSE: GSK) FDA-mandated QT prolongation study. The communication can be found at: http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm.

Zofran 32 mg Dose Banned by FDA as it May Cause Potentially Fatal QT Prolongation. Specifically, the FDA is informing healthcare officials that a single 32 mg dose of Zofran affects the electrical activity of the heart, resulting in QT prolongation. This could “pre-dispose patients to develop an abnormal and potentially fatal heat rhythm known as Torsades de Pointes.” While the 32 mg dose is therefore unsafe, the label still states that Zofran can be administered in adults and children with chemotherapy-induced nausea and vomiting (CINV) at a dose of 0.15 mg/kg every 4 hours for three doses per day with no single dose exceeding 16 mg. For example, assuming that the average cancer patient’s weight is 65-75 kg, this would mean that each administration would equate to 10-11 mg for a total of 30-33 mg administered over 12 hours (TID).

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