TAP Holdings received clearance from the FDA to market Lupron Depot(R)-4 Month 30 mg (leuprolide acetate for depot suspension) for palliative treatment of advanced prostate cancer. Because of the drug's long-acting formulation, patients receive only one injection of Lupron Depot-4 Month 30 mg every 16 weeks to treat their condition.
In clinical trials, the safety and efficacy of Lupron Depot-4 Month 30 mg were similar to the other Lupron Depot formulations.
The most common side effect reported with Lupron Depot-4 Month 30 mg was hot flashes. Serum testosterone levels may increase approximately 50 percent above baseline during the first week of treatment. Like other treatment options, it may also cause impotence. Symptoms may worsen over the first few weeks of treatment. Lupron Depot is contraindicated in patients who exhibit hypersensitivity to GnRH, GnRH agonist analogs or any excipients in the product. This formulation is not indicated for use in women.
Lupron Depot is in a class of drugs known as gonadotropin releasing hormone (GnRH) analogs. It works by inhibiting the production of the hormone testosterone, which may play a significant role in the growth of prostate cancer. Decreasing the levels of testosterone in the body may also alleviate bone pain and some urinary problems that may be associated with metastatic prostate cancer.
Prostate cancer is now the second leading cause of cancer deaths in men. In 1997, the American Cancer Society estimated that 334,500 men were newly diagnosed with prostate cancer and that approximately 41,800 will die from the disease in 1997.