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Injectable Fosaprepitant Dimeglumine Clears FDA Hurdle

WHITEHOUSE STATION, N.J., Jan. 29, 2008 - Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Emend (fosaprepitant dimeglumine) for Injection, a new intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV). Emend for Injection is an intravenous prodrug of the oral formulation of Emend (aprepitant), which means that when Emend for Injection is administered, fosaprepitant is rapidly converted in the body to aprepitant. Emend for Injection is approved for use in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic and highly emetogenic cancer chemotherapy, including high-dose cisplatin.

Emend for Injection (115 mg) provides a new option for patients receiving an antiemetic on Day 1 of their chemotherapy. Emend for Injection (115 mg) may be substituted for the 125 mg oral capsule of Emend on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. The three-day antiemetic regimen includes Emend for Injection (115 mg) or Emend (125 mg orally) on Day 1; Emend (80 mg orally) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist.

"Nausea and vomiting are among the top concerns that people have when they receive chemotherapy and, to an oncologist, are very important to control," said Lee Schwartzberg, M.D., clinical oncologist and professor of medicine at the University of Tennessee Health Science Center. "While the oral formulation of Emend is appropriate for many patients, the approval of Emend for Injection provides healthcare professionals and their patients with a new option in helping to prevent nausea and vomiting caused by chemotherapy."

The FDA approval for Emend for Injection was based on a study that showed 115 mg of intravenous Emend for Injection was biologically equivalent to 125 mg of oral Emend. Adverse events reported in the study, regardless of causality, included infusion site pain (7.6 percent), infusion site induration (1.5 percent) and headache (3 percent). Because Emend for Injection is converted to aprepitant, common side effects observed with oral Emend might also be expected to occur with Emend for Injection, including tiredness, nausea, hiccups, constipation, diarrhea, loss of appetite, headache and hair loss.

Important information about Emend for Injection and Emend
Emend for Injection and oral Emend, when used in combination with other antiemetics, are only used to help prevent nausea and vomiting caused by chemotherapy. They are not used to treat nausea and vomiting after they start.

Patients should tell their doctor about all other medicines, vitamins or herbal supplements they are taking, if they are pregnant or plan to become pregnant, if they are breastfeeding or if they have liver problems. Patients should not take Emend for Injection or oral Emend with Orap® (pimozide), Seldane® (terfenadine), Hismanal® (astemizole) or Propulsid® (cisapride) as the combination may cause serious or life-threatening problems if taken together. Emend for Injection and oral Emend may also affect some medicines, including chemotherapy, causing them to work differently in the body. Patients taking Coumadin® (warfarin) may need to have blood tests after taking Emend for Injection or oral Emend to check their blood clotting. Women who use birth control medicines during treatment with Emend for Injection and oral Emend and for up to one month after administration of Emend for Injection and oral Emend should also use a backup method of contraception to avoid pregnancy.

New packaging for Emend capsules
To assist patients in following the required three-day dosing regimen for Emend, new packaging will be available. In addition to the current three-dose oral regimen tri-pack containing one 125 mg capsule and two 80 mg capsules, a new two-dose bi-pack has been developed containing two 80 mg oral capsules of Emend. Emend for Injection will be packaged separately as a single-dose vial.

About Emend and Emend for Injection
Outside the United States, fosaprepitant dimeglumine is approved for use in the European Union and Australia, with marketing applications under review by a number of other regulatory agencies.

Emend and Emend for Injection belong to a class of medications called substance P/neurokinin 1 (NK-1) receptor antagonists and are believed to work through a novel mechanism, which primarily blocks nausea and vomiting signals to the brain. Emend (aprepritant) oral capsules are currently recommended as one part of standard antiemetic regimens to prevent the acute or delayed nausea and vomiting caused by specified chemotherapies by major clinical oncology treatment guidelines, including the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), the Multinational Association of Supportive Care in Cancer (MASCC) and the National Comprehensive Cancer Network (NCCN).

To provide patients with reimbursement information as well as to assist those who cannot afford the medicine, Merck has developed the Accessing Coverage Today (ACT) Program. The ACT Program provides easy and free support services for patients that have been prescribed Emend or Emend for Injection. The toll-free number is 1-866-363-6379.

Source: Merck & Co.

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