• 11/6/2001
  • MGI PHARMA, INC, Press release

MGI PHARMA, INC., (Nasdaq:MOGN) today announced that the Radiation Therapy Oncology Group (RTOG) presented final results on data regarding the Company’s Salagen(R) Tablets product at this year’s American Society for Therapeutic Radiology and Oncology (ASTRO) meeting held in San Francisco on November 4-8, 2001. The resulting data were discussed by Dr. Charles W. Scarantino, lead investigator of the RTOG study on Salagen Tablets, in his presentation entitled: “A Phase 3 study on the concurrent use of pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head an neck cancer patients – final results of RTOG 97-09.”

Study Data

The RTOG presented data showing that use of Salagen(R) Tablets (pilocarpine hydrochloride), MGI’s approved product to treat the symptoms of radiation-induced dry mouth, gave a statistically significant improvement of salivary flow versus placebo in head and neck cancer patients receiving curative radiation therapy. This Phase 3 trial, with 244 eligible patients, showed the pilocarpine group, who received active drug during radiation therapy and up to six months post therapy, had significantly better salivary flow than did the placebo group at end of radiation therapy, and at three-month and six-month follow-up visits. Based on these findings, RTOG concluded that these results provide new support for the use of Salagen Tablets during radiation treatment.

One of the main side effects of radiation therapy for head and neck cancer patients is dry mouth, a condition that can be permanent, according to Dr. Scarantino, a radiation oncologist with the Rex Healthcare Center, Raleigh, NC, and Southeastern Cancer Control Consortium. “We are quite pleased with the results of the study in that by taking pilocarpine three or four times a day in pill form, salivary flow was better than taking placebo,” said Dr. Scarantino. “These were just the results we were hoping for and we believe we can now build on this study in the future. These clinical results are of real importance to cancer patients.”

Dr. Scarantino said that although the drug had a real impact on dry mouth symptoms, it did not have an effect on mucositis, another side-effect of radiation treatment for head and neck cancer. Mucositis is a painful condition associated with inflammation of the mucous membrane.

About Salagen(R) Tablets

MGI developed and markets Salagen Tablets for the treatment of chronic dry mouth symptoms associated with head and neck cancer patients treated with radiation, and with Sjogren’s syndrome patients. MGI has marketed Salagen Tablets in the United States for the cancer-related indication since 1994 and the Sjogren’s syndrome indication since 1998. Salagen Tablets are the first and only prescription medication approved in the United States for treating dry mouth symptoms associated with both of these patient populations. Chronic dry mouth can be a potentially painful and debilitating condition. Salagen Tablets stimulate the exocrine glands, including the salivary glands, to increase their moisture-producing activity.

When head and neck cancer patients receive radiation treatment, this therapy often damages the salivary glands and their ability to produce moisture. Salagen Tablets can stimulate the glands to generate more moisture.

Salagen Tablets do not work for everyone and are contraindicated when uncontrolled asthma is present and when miosis is undesirable. When used for radiation-induced xerostomia, the most common side effect is sweating. Although less frequent, in some people, headache, flushing, and frequent urination can also occur. When used for Sjogren’s syndrome, the most common side effect is sweating, and in some people, chills, flushing, and frequent urination can occur.

**The Radiation Therapy Oncology Group (RTOG) is a federally funded cancer clinical trials cooperative group, which carries out multi-disciplinary research nationwide. It is a major clinical research component of the American College of Radiology.