Matrix Pharmaceutical, Inc, announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for cisplatin/epinephrine (IntraDose) injectable gel for the treatment of refractory or recurrent head
Matrix Pharmaceutical, Inc, announced that the US Food andDrug Administration (FDA) has accepted the filing of a New Drug Application(NDA) for cisplatin/epinephrine (IntraDose) injectable gel for the treatment ofrefractory or recurrent head and neck cancer.
"We are very pleased that the FDA has accepted ourIntraDose NDA," said Michael Casey, president, chief executive officer, andchairman of Matrix. "The NDA filing was the major focus of the companyduring the year 2000. We submitted the Pharmacology/Toxicology and Chemistry,Manufacturing, and Controls sections of the IntraDose NDA during 2000. We willcontinue 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 Centerfor Drug Evaluation and Research, the goal of the FDA is to complete standardreviews on NDA submissions in 2001 within 12 months.
The combination of cisplatin and epinephrine is a potential newapproach to treating locally recurrent or metastatic cancer. The agent delivershigh concentrations of cisplatin for an extended time at the injection sitewhile reducing systemic effects associated with intravenous administration. Thecompany’s NDA filing is based on the results of two phase III trials completedin 2000. The goal for these studies is to achieve local or regional control ofthe cancer while improving the quality of life for patients with head and neckcancer.