Spectrum says prostate drug is successful

Ozarelix is used in the treatment of Benign Prostatic Hypertrophy (BPH), an enlargement of the prostate gland.

The trial was conducted in Europe in collaboration with Spectrum’s partner Aeterna Zentaris. In August 2004, Spectrum received an exclusive license from Aeterna to develop and market Ozarelix for all potential indications in North America and India.

The results showed the drug significantly improved symptoms of BPH. Other efficacy endpoints of the study such as urine flow and quality of life were also met. In addition, the drug had an excellent safety profile.

“We are encouraged by the safety and efficacy results demonstrated in the phase II trial of our proprietary drug, Ozarelix, and we plan to move the drug into phase III as expeditiously as possible,” said Rajesh Shrotriya, president and CEO of Spectrum. “We are currently preparing an information package, which we expect to present to the FDA by the beginning of 2007.”

While the primary efficacy endpoint was achieved at all dosage regimens, the best results were obtained with the 15 mg dose of Ozarelix. The drug was also shown to have long lasting effects.