Indevus Pharmaceuticals received FDA approval for its once-daily muscarinic receptor antagonist Sanctura XR (trospium) for treatment of urinary incontinence Aug. 6.

East Brunswick, N.J.-based Esprit Pharma has U.S. rights to market Sanctura , which was approved in 2004, and will market Sanctura XR as well with its 180-person specialty sales force. Indevus will co-market the drug with about 75 of its own sales reps, according to Indevus VP-Corporate Communications Brooke D. Wagner.

The Sanctura XR approval is one of several milestones the firm expects this year. Its Supprelin LA (histrelin acetate) subcutaneous implant was approved in May for treatment of precocious puberty. The firm plans to submit an NDA at the end of summer for Nebido , a long-acting testosterone candidate to treat male hypogonadism (¹ Also see "Indevus Plans End-Of-Summer NDA For Nebido Following Positive Phase III Results" - Pink Sheet, 7 June, 2007.).

Indevus also submitted an sNDA in April for Valstar (valrubicin) for bladder cancer and plans to reintroduce the product in late 2007 or early 2008. The Lexington, Mass., company made an all-stock purchase of Valera Pharmaceuticals in December 2006, gaining Supprelin LA and Valstar (² Also see "Indevus Gains Supprelin LA With Purchase Of Valera" - Pink Sheet, 12 December, 2006.).

Phase III clinical trials for the incontinence product met the primary endpoints of reduction in frequency of urination and reduction in number of urge incontinence episodes (³ Also see "Sanctura XR Could Quench Indevus’ Thirst For Once-Daily Incontinence Therapy" - Pink Sheet, 15 June, 2006.).

Most commonly reported side effects included dry mouth (10.7 percent for Sanctura XR versus 3.7 percent for placebo) and constipation (8.5 percent for treated group, 1.5 percent for placebo group).

Indevus estimates the market for the drug to be about $1.6 billion, growing at 10 percent annually. However, Sanctura XR will compete in an already crowded space.

The company emphasizes, though, that Sanctura XR is "highly differentiated from other products" Wagner told "The Pink Sheet" DAILY. Sanctura XR has "the lowest dry mouth in its class." Plus, "it has a different chemical structure ... so it does not cross membranes very well. The other products have significant side effect issues, at least in their labels. We don't have any drug-drug metabolic interactions, because it's not metabolized by the liver where the other drugs are metabolized," he said.

Johnson & Johnson's Ditropan XL (oxybutynin), Pfizer's Detrol LA (tolterodine) and Watson's oxybutynin patch, Oxytrol , all offer extended-release dosing. GlaxoSmithKline/Astellas offers Vesicare (solifenacin) and Novartis/Procter & Gamble has Enablex (darifenacin) to treat overactive bladder.

In addition, Pfizer received an "approvable" letter from FDA in January for fesoterodine for the same indication.

Indevus will release its third quarter 2007 financial results in a conference call with investors Aug. 7.

-Pamela Taulbee (p.taulbee@elsevier.com)

Indevus Gains Sanctura XR Approval

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