Nutley, NJ and Clifton, NJ – October, 1998 – Hoffmann-La Roche Inc. and Oxford Pharmaceutical Services Inc., announced today that Oxford is acquiring ownership of the NDA for the antidepressant product MarplanÂ® (isocarboxazid) from Roche. Oxford will assume sales, marketing and distribution of MarplanÂ® November 13, 1998. Orders for MarplanÂ® should be directed to Oxford Pharmaceutical Services, Inc., 1585 US Highway 46 West, Totowa, NJ 07512. Questions or requests for prescribing information on MarplanÂ® should be addressed to Dr. Richard Guarino – telephone number 973-256-0600, fax number 973-837-0572, e-mail email@example.com.
MarplanÂ®, a monoamine oxidase (MAO) inhibitor, is indicated as a second-line treatment for depression. “MarplanÂ® is an important option for patients who are unresponsive to other antidepressants such as: SSRIs or traditional antidepressants like amitriptyline. MarplanÂ® has shown significant efficacy in treating depression, and, for certain patients, may offer relief from depression that they otherwise might not be able to achieve,” said Richard A. Guarino, M.D., President of Oxford.
Roche will manufacture the initial supplies of MarplanÂ® for Oxford, after which Oxford will assume responsibility for the manufacturing of this product.
On August 18, the U.S. Food and Drug Administration approved a supplemental New Drug Application for MarplanÂ®. This supplemental NDA was prepared by Oxford Research International Corp., an affiliated company of Oxford Pharmaceutical Services Inc. This supplemental submission was based on clinical studies conducted by Roche, which provided proof of the effectiveness of MarplanÂ® under present day requirements. This supplemental NDA was submitted and approval obtained to resolve the Drug Efficacy Study Implementation (DESI) status of MarplanÂ®. The new labeling for MarplanÂ® provides for daily dosages up to 60 mg per day, compared to prior labeling which had a maximum daily dosage of 30 mg/day.
As part of the approval, Oxford has agreed to conduct a follow-up open label safety study for 30 mg, 50 mg and 60 mg daily doses of MarplanÂ®. It is presently planned to complete this study toward the end of 2000.
MarplanÂ® was originally introduced in 1959. In 1994, as a result of the DESI review and marketing considerations Roche discontinued marketing the product. Patient and physician demand for MarplanÂ® led Roche to provide the product to patients through a compassionate use program on an as-needed basis. The sale to Oxford will again make MarplanÂ® available on the market.
“We’re delighted to be able to offer this medication for sale once again,” said Guarino. “For people who haven’t responded to other antidepressants, it can make the difference in their ability to perform their daily living activities.”
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. Among the company’s areas of therapeutic interest are virology, including HIV and AIDS, infectious diseases, cardiology, neurology, oncology, transplantation, dermatology and obesity.
Editor’s Note: Full prescribing information available upon request to the medical profession from: