Merck's EMEND- We have discussed this on in the biotech short thread:
FDA Approves EMEND -aprepitant-, Merck's New Medicine to Prevent Nausea and Vomiting in Chemotherapy Patients
Wednesday March 26, 8:12 pm ET
First in a New Class to Help Protect Patients from Nausea and Vomiting Triggered by Highly Emetogenic Chemotherapy
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--March 26, 2003-- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved EMEND® (aprepitant). EMEND (EE-mend), the first member in a new class of medicines, will be used in combination with other anti-vomiting medicines to help prevent the acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin.
"Nausea and vomiting are two common complications of cancer chemotherapy and can lead to considerable distress and disruption in patients' lives," said Scott Reines, M.D., Ph.D., vice president, Clinical Research, Merck Research Laboratories. "EMEND is a new medicine that will help more patients to avoid symptoms of nausea and vomiting for up to five days after their chemotherapy treatment."
EMEND, a Substance P/Neurokinin 1 (NK(1)) receptor antagonist, is the first medicine indicated for the prevention of delayed symptoms - the nausea and vomiting that can occur after the first day and can go on for several days following highly emetogenic chemotherapy. Highly emetogenic chemotherapy is the type of chemotherapy that causes most patients to vomit if they do not receive anti-vomiting medicine prior to their treatment.
EMEND is an oral capsule that is used in combination with other anti-vomiting medicines. EMEND is taken once daily for three days. The recommended dosing regimen is EMEND 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg once daily in the morning on Days 2 and 3. EMEND may be taken with or without food. Chronic continuous use of EMEND for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.
EMEND is a prescription medicine and should not be taken with pimozide, terfenadine, astemizole, and cisapride. EMEND should not be used by patients who are allergic to any ingredient of the product.
Patients should talk to their doctor about all the other medicines they are taking, or if they are pregnant or plan to become pregnant, or are breast-feeding or have liver problems.
Regimen with EMEND prevented symptoms better than standard therapy
"Nausea and vomiting are among the top concerns that people have when they receive chemotherapy," said Dr. Steven Grunberg, professor of medicine, University of Vermont. Approximately half of all patients receiving highly emetogenic chemotherapy experience delayed nausea and vomiting despite the use of currently available anti-vomiting medicines.
In two multinational clinical studies, EMEND in combination with a 5-HT(3) receptor antagonist and a corticosteroid ("regimen with EMEND") was compared with a 5-HT(3) receptor antagonist and a corticosteroid alone ("standard therapy"). The dose of corticosteroid in the regimen with EMEND was reduced to achieve drug levels similar to those achieved with standard therapy.
In these clinical studies, the regimen with EMEND provided significantly improved protection for five days against both acute (within 24 hours of chemotherapy) and delayed nausea and vomiting compared to standard therapy. In both studies, more patients on the regimen with EMEND as compared with standard therapy had a "complete response" to therapy - defined as no vomiting and no use of rescue medicines. The improvement in overall complete response in each study was approximately 20 percentage points. The specific results from the studies were:
Patients with complete response
Regimen with EMEND Standard
therapy
Study #1 Total # of Patients 260 261
Overall (0 to 120 hours) 73% 52%
Acute (0 to 24 hours) 89% 78%
Delayed (25 to 120 hours) 75% 56%
Study #2 Total # of Patients 261 263
Overall 63% 43%
Acute 83% 68%
Delayed 68% 47%
A total of 1105 patients were randomized to receive either a regimen with EMEND (550 patients) or standard therapy (555 patients). The standard therapy used in the clinical studies with EMEND is consistent with current American Society of Clinical Oncology (ASCO) treatment guidelines.
Less impact of nausea and vomiting on patients' daily lives
The impact of nausea and vomiting on patients' lives was also evaluated in the clinical studies with EMEND. The analysis showed that more patients on the regimen with EMEND reported minimal or no impact of nausea and vomiting on their daily lives compared to standard therapy (Study 1: 74% versus 64%; Study 2: 75% versus 64%).
"As an oncologist, the ability to control chemotherapy-induced nausea and vomiting through new therapies, not only for the day of treatment but for several days after, is particularly important," said Dr. Steven Grunberg, professor of medicine, University of Vermont.
Protection maintained over multiple chemotherapy cycles
More than two thirds of patients received more than one cycle of chemotherapy in the two clinical studies, and approximately one third continued through six cycles. The results from these extension studies showed that the improved prevention of nausea and vomiting with the regimen with EMEND was maintained cycle after cycle of chemotherapy.
Regimen with EMEND was generally well tolerated
The overall safety of aprepitant was evaluated in approximately 3300 individuals. In two well-controlled clinical studies in patients receiving highly emetogenic chemotherapy, 544 patients were treated with aprepitant during the first cycle of chemotherapy, and 413 of these patients continued into the multiple cycle extension for up to six cycles of chemotherapy.
The regimen with EMEND was generally well tolerated in these clinical studies. The most commonly reported side effects were tiredness, nausea, hiccups, constipation, diarrhea, and loss of appetite.
Important information about EMEND
Patients should talk to their doctor about all the other medications they are taking. EMEND may cause serious life-threatening reactions if used with certain medicines. Some medicines can affect EMEND. EMEND may also affect some medicines, including chemotherapy, causing them to work differently in the body.
Doctors may check to make sure their patients' other medicines are working properly, while they are taking EMEND. Patients taking warfarin therapy may need to have more frequent blood tests after each 3-day regimen of EMEND to check their blood clotting.
Women using birth control pills while taking EMEND should also use a back-up method of contraception to avoid pregnancy.
Patients should read the patient information before starting therapy with EMEND and reread it each time the prescription is renewed in case any information has changed.
EMEND is not used to treat nausea and vomiting that patients already have.
EMEND offers new way to protect against nausea and vomiting
Multiple neurotransmitters (chemical substances that transmit nerve impulses) are implicated in nausea and vomiting. EMEND is believed to work through a novel mechanism which blocks the nausea and vomiting signals transmitted by the neurotransmitter, Substance P, in the brain. This mechanism is distinct from how current anti-vomiting medicines work.
Therefore, by blocking the actions of multiple neurotransmitters, a regimen of EMEND combined with other medicines works to provide improved prevention against acute as well as delayed nausea and vomiting.
EMEND available soon
EMEND was discovered and developed in Merck's research laboratories. The medicine will be available as a convenient three-dose tri-pack containing the dose that is specific for each day of treatment: one 125 mg capsule (white/pink) and two 80 mg capsules (white). Patients will bring one tri-pack to the hospital clinic or physician office on the first day of chemotherapy treatment so that the Day 1 dose may be administered one hour prior to chemotherapy.
EMEND will be available in pharmacies starting the week of April 14. The catalogue price is $250.00 for the standard three-day dosing regimen. Merck has also developed the Accessing Coverage Today (ACT) Program for EMEND to provide patients with reimbursement information as well as to assist those who cannot afford EMEND. The toll-free number is 1-866-EME-NDrx. |
