Matrix Pharmaceutical, Inc, announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for cisplatin(Drug information on cisplatin)/epinephrine (IntraDose) injectable gel for the treatment of refractory or recurrent head and neck cancer.
"We are very pleased that the FDA has accepted our IntraDose NDA," said Michael Casey, president, chief executive officer, and chairman of Matrix. "The NDA filing was the major focus of the company during the year 2000. We submitted the Pharmacology/Toxicology and Chemistry, Manufacturing, and Controls sections of the IntraDose NDA during 2000. We will continue to work closely with the agency to facilitate the review process."
FDA’s Standard Review Goal
The FDA has designated the application for standard review. According to the published performance goals and procedures of the FDA Center for Drug Evaluation and Research, the goal of the FDA is to complete standard reviews on NDA submissions in 2001 within 12 months.
The combination of cisplatin and epinephrine(Drug information on epinephrine) is a potential new approach to treating locally recurrent or metastatic cancer. The agent delivers high concentrations of cisplatin for an extended time at the injection site while reducing systemic effects associated with intravenous administration. The company’s NDA filing is based on the results of two phase III trials completed in 2000. The goal for these studies is to achieve local or regional control of the cancer while improving the quality of life for patients with head and neck cancer.