Depomed Inc. filed a new drug application for Proquin XR, a once-daily, extended-release formulation of the antibiotic ciprofloxacin, proposed for the treatment of uncomplicated urinary tract infections.
John Fara, president, CEO and chairman of Menlo Park, Calif.-based Depomed, told BioWorld Today he expects a 12-month review period.
Submission of the Proquin XR NDA almost immediately follows the firm's filing of an application for Glumetza, a once-daily, extended-release formulation of metformin HCl for treatment of Type II diabetes. Depomed and partner Biovail Corp., of Toronto, in late June said the FDA had accepted the Glumetza application for review.
Fara said, "We've met all of our projections, and I think for a young company to take two products through full development in four years with very good Phase III data and to file two NDAs within three months is very significant."
Depomed used its Gastric Retention technology to design Proquin XR for preferential absorption in the upper intestine. In clinical trials, patients treated with Proquin XR demonstrated significantly fewer side effects, including nausea and diarrhea, Fara said.
Indeed, the NDA is based on a Phase III trial that involved 1,037 patients with uncomplicated urinary tract infections. The trial evaluated the efficacy and safety of a three-day course of treatment with once-daily Proquin XR, compared to a three-day course with twice-daily Cipro, an immediate-release antibiotic made by Bayer AG, of Leverkusen, Germany.
Overall gastrointestinal disorders were reported in 2.9 percent of patients treated with Proquin XR and 5.1 percent in patients treated with Cipro. Notably, there were fivefold fewer complaints of nausea and sevenfold fewer cases of diarrhea reported in the Proquin XR group, compared to the Cipro group, the company said.
Preliminary analysis showed a microbial eradication rate of 93.4 percent in the Proquin XR arm, compared with 89.6 percent with Cipro.
While the trial involved 1,037 patients, only 540 were evaluable in that they completed the trial. In order to be evaluated, patients needed follow-up at day seven and day 30. However, many were cured after three days and did not return for follow-up, Depomed said.
Fara said the company is in discussions regarding partnership options.
Behind Proquin XR and Glumetza, Depomed is running a Phase II trial with the diuretic Furosemide GR in congestive heart failure and plans to initiate a Phase II trial with the seizure and pain drug Gabapentin GR later in 2004.
Depomed's stock (NASDAQ:DEPO) Tuesday rose 27 cents to close at $4.54.