Indevus Pharmaceuticals Inc. got the good news it was waiting for, reporting that its product for overactive bladder, trospium, nailed both primary endpoints and hit its secondary endpoints as well in a Phase III trial.

With data showing patients experienced significantly reduced frequencies of urination and urinary incontinence episodes when compared to patients receiving placebo, Indevus said it would aim for a second-quarter 2003 new drug application filing that would include a wealth of European trial data.

"The results were unequivocally positive. By that I mean they not only hit the two primary endpoints, but they met a host of secondary endpoints," said William Boni, vice president, corporate communications at Indevus. "The robust internal consistency of the trial was as impressive as the fact that it hit the primary endpoints."

Lexington, Mass.-based Indevus' stock (NASDAQ:IDEV) rose 66 cents Tuesday, or 56.9 percent, to close at $1.82.

The double-blind trospium trial took place at 50 U.S. sites and involved 523 patients. The "p" values for both primary endpoints were less than or equal to 0.01, or "a pretty positive p number," as Boni called them, when compared to the requisite 0.05 needed for statistical significance. Indevus plans to publish full data from the trial sometime next year.

Trospium comes from a class of anticholinergic compounds called muscarinic receptor antagonists. It is designed to relax smooth muscle tissue found in the bladder and therefore decrease bladder contractions.

Trospium already is approved in Europe - Indevus licensed the U.S. rights to the product from Madaus AG, of Köln, Germany, in 1999. Boni said Indevus has spoken with the FDA and discussed combining the Phase III results with a database from European clinical trials of trospium from both before and after it was approved in Europe. The database has more than 2,200 patients in it and includes data from five double-blind, placebo-controlled trials and several comparative studies.

"This trial will be sufficient to file with the FDA with the European clinical database," Boni told BioWorld Today, adding that Indevus has met with the FDA and reviewed the database.

As of now, trospium is unpartnered in the U.S., but Indevus is examining its options.

"We own exclusive rights and are looking to partner the asset with an organization," Boni said, either a contract sales company or a pharmaceutical company. But, he said, Indevus will "certainly look to participate in the marketing of this product itself, perhaps through a specialty sales force."

The U.S. market leaders for this indication, Ditropan (Ortho-McNeil Pharmaceutical) and Detrol (Pharmacia Corp.), combined to generate $750 million in revenue last year. The overall market for overactive bladder is expected to grow to $1 billion in the U.S. next year and $2 billion by 2008, Boni said.

"It's a fast-growing market and we would hope that, based on trospium results in this trial and Europe, we would be able to be very competitive with both of those products," Boni said.

Indevus' other main product, pagoclone, is stalled. The anti-anxiety product been in six clinical trials in generalized anxiety disorder and panic disorder - not all of them successful, causing Indevus' partner, Pfizer Inc., of New York, to return rights in June. Aventis SA, of Strasbourg, France, had an option to pick up pagoclone, but it chose not to. Indevus is looking to repartner the drug, and Boni said discussions have been initiated since Aventis declined its option early this month. For now the product remains in need of a comprehensive Phase III program. (See BioWorld Today, June 10, 2002, and Sept. 3, 2002.)

But, saying "the name of the game is to get a product to market," Boni and Indevus have reason to be happy.

"It is great data," Boni said. "It's the single most important step in filing the NDA for trospium. An event like this has the potential to transform any company."