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 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 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