The U.S. Food and Drug Administration is consulting with the drugmaker on rewording the device’s instructions and Pfizer is considering changes to the product design, said company spokeswoman Sally Beatty. Beatty said Caverject still can be ordered without the delivery system by pharmacists.

“Pfizer is optimizing the Caverject Impulse to improve its ease of use for patients,” Beatty said. According to a Pfizer Web site, www.caverject.com, the manufacturer is developing and testing more detailed user instructions for the prefilled syringe with a dial for exact dosing.

John Mulhall, MD, an urologist and director of the Male Sexual & Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center in New York, says he understands that Pfizer’s withdrawal of Caverject Impulse is temporary.

“We do have some patients who are on Caverject; they use the regular (syringe) Caverject system at the moment,” he said. “My understanding talking to the Pfizer people not too long ago is that Caverject Impulse is not a discontinued product; it’s going to be available at some point in the future. It’s just a matter of a negotiation between the FDA and Pfizer for a label change regarding the instructions.” FDA spokeswoman Rita Chappelle referred questions to Pfizer. Alprostadil, also known as prostaglandin E1 (PGE1), is the main ingredient in Caverject. While oral ED drugs such as Viagra have become popular in the last few years, alprostadil injections may be the only option for men who are taking other medications that may cause an adverse interaction.

Users of Caverject have other options. Besides a comparable drug known as EDEX, produced by international drugmaker UCB, many consumers have found multi-agent or combination therapies effective, Mulhall said. A majority of his patients at Sloan-Kettering bypass Caverject and EDEX because of pain associated with the injection of prostaglandin, he said. Many compounding pharmacies offer multi-agents that combine two or three chemicals to make a product similar to Caverject.

One, called Bimix, is a blend of papaverine and phentolamine, but does not contain prostaglandin E1 and might be a preferred choice for patients who complain of pain from injections that contain PGE1. Another combination therapy, Trimix, adds PGE1. Beatty said Caverject users should speak with their healthcare providers about continuing to use Caverject with an alternative injection system. EDEX is being delivered to pharmacies as scheduled, according to UCB.

“Production on EDEX has not been halted,” says UCB spokeswoman Anne Kirby.

The phase 3 trial included patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors, the company said in a news release.

The trial results prompted an independent Data Monitoring Committee to recommended halting the test after concluding that Sutent (sunitinib malate) showed greater "progression-free survival" than a placebo, the company said.

"These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors," Dr. Mace Rothenberg, Pfizer's senior vice president of medical development and clinical affairs, said in the release.

The company said all participants in the trial will have the choice of continuing treatment with Sutent or switching from a placebo to the drug. Complete data from the trial is being "analyzed and more details will be presented at an upcoming scientific meeting," the news release said. Details on the duration of survival benefit for those using Sutent have not yet been released.

Pancreatic islet cell tumors are rare malignancies of the pancreas, with an incidence of five million to 10 per million worldwide annually, Pfizer said.

Steve Jobs, chief executive officer of Apple Inc., said he was diagnosed in 2004 with that form of the disease, Bloomberg News reported.

Sutent has already been approved by the U.S. Food and Drug Administration for the treatment of certain kidney and stomach cancers. More than 38,000 patients worldwide have been treated with the drug in the clinical setting and trials, Pfizer said.

Sutent has also been the subject of controversy, after recent studies suggested it might boost patients' blood pressure and increase their risk for heart failure. In December, Pfizer issued a statement saying that these cardiovascular risks "were medically manageable in most patients and underscore the importance of having a collaborative team of health-care professionals working together to appropriately manage patients who have limited available options" in treating their cancer.

The company said today it has inked a set of deals with Indian generics maker Aurobindo Pharma for rights to 39 generic oral drugs in the U.S. and 31 in Europe, including 11 in France alone. The drugs are for heart disease and neurological disorders, among other things. The company will sell the drugs in the U.S. through its Greenstone generics unit.

Pfizer also acquired rights to 12 injectable antibiotics in the U.S. and Europe. Pfizer didn’t disclose the deal terms but said the agreements expanded a five-product U.S. deal entered into with Aurobindo in July.

This past fall, Pfizer said it was warming to the idea of building its generics business, despite the branded industry’s traditional antipathy toward generics companies whose copycat products eat into branded sales. As branded makers’ big drugs go off patent, the generics that replace them can become a steady stream of revenue, on a smaller scale. Pfizer said it expects to reap $200 million in annual sales from the recent agreements with Aurobindo by 2013.

Pfizer said today it sees its latest move as contributing to “an engine of positive growth.” Other branded makers focusing on generics include Novartis, which has a well-established Sandoz generics unit, and Merck, which has said it wants to get into generic biotech.