ALZA Corp. submitted a new drug application for approval of dapoxetine hydrochloride, a treatment for premature ejaculation.

If approved, it will be the first prescription product designed specifically for treating PE, said Ellen Rose, spokeswoman for the Mountain View, Calif.-based company.

"It's a new oral medication specifically developed to treat PE, premature ejaculation," Rose said, adding that PE is "the most common form of male sexual dysfunction that affects about one-third of men worldwide."

The company could not comment on when it can expect a response from the FDA, she said.

A selective serotonin reuptake inhibitor, dapoxetine hydrochloride is a "unique pharmacological product that inhibits the serotonin transmitter," the neurotransmitter that causes ejaculation, Rose said.

Details of ALZA's Phase III trials have not yet been released.

"We'll be presenting clinical data in scientific forums in the first half of 2005," Rose said.

The product will be marketed in the U.S. by Ortho-McNeil Pharmaceutical Inc. Both ALZA and Ortho-McNeil are subsidiaries of New Brunswick, N.J.-based Johnson & Johnson.

The company has long-term plans to sell the product outside the U.S., she said.

Rose said she could not provide marketing or sales estimates of dapoxetine hydrochloride and said neither ALZA nor Ortho-McNeil has announced the name under which dapoxetine hydrochloride might be sold.

ALZA has worked to develop the product since licensing dapoxetine from PPD Inc., of Wilmington, N.C., in January 2001. Under terms of that agreement, ALZA received worldwide rights to develop and commercialize the product and bears the responsibility for manufacturing, clinical, regulatory and marketing costs, while PPD received an undisclosed up-front payment and would receive royalties.

PPD, in turn, had in-licensed dapoxetine from Indianapolis-based Eli Lilly and Co. in 1998 before out-licensing it to ALZA. In December 2003, PPD purchased the dapoxetine patents from Lilly for $65 million, thereby terminating their license agreement. At the time, dapoxetine was in Phase III trials under ALZA, and PPD officials estimated dapoxetine could sell $750 million at its peak. (See BioWorld Today, Dec. 22, 2003.)

In January, ALZA amended the dapoxetine license agreement with PPD so that certain sales-based payments would be abated for a period following NDA approval. ALZA would make a cash payment to PPD and agreed to a fixed milestone payment upon FDA approval.

PPD completed some Phase II work on dapoxetine before licensing it to ALZA, which conducted its own trials, Rose said.

ALZA, which focuses on drug delivery platforms, in July received an FDA approvable letter regarding its on-demand acute pain product, Ionsys.

The application for Ionsys, an iontophoretic, fentanyl-containing transdermal analgesic, was submitted in September 2003. The product is a credit card-sized patch.