FDA process soon to begin for NU drug

Dalia Naamani-Goldman

The Food and Drug Administration will begin the approval process in coming weeks for a drug created by a Northwestern professor and developed by Pfizer Inc. that could bring hundreds of millions of dollars to the university.

Pfizer will submit pregabalin to the FDA later this month to be considered for treatment of neuropathic pain, epilepsy, adjunctive therapy and generalized anxiety disorder, according to Shreya Prudlo of Pfizer’s corporate media relations department. She said Pfizer “doesn’t project future revenue” and could not comment on the drug’s estimated economic impact.

Pregabalin reduces pain transmission in the central nervous system. Biochemistry Prof. Richard Silverman developed it in 1989 and the drug has since been tested in many clinical trials across the country. Pfizer is licensed to develop the drug.

Indrani Mukharji, executive director of NU’s technology transfer program, said she could not release any information about pregabalin until early November.

The FDA also declined to comment on the issue. An FDA spokeswoman said the agency cannot release any information on unapproved drugs. She said drug approval applications submitted to the FDA are reviewed and approved within six to 10 months.

Datamonitor, a London-based business-information company, predicted in a July 2003 pharmaceutical industry report that pregabalin would be launched in 2004 and could bring in $760 million in 2005 and jump up to $1.9 billion per year by 2008. According to the report, pregabalin is the second-largest “potential pipeline blockbuster” in the drug industry through 2008.

University President Henry Bienen said last year that NU would receive 6 percent of pregabalin’s yearly revenue if it hit the market. Under Datamonitor’s projections, NU’s share of the profits would be between $45 million and $114 million annually through 2008, with the potential for more in subsequent years. Bienen has said in the past that the money likely would be put toward the university’s endowment and building funds and create more graduate fellowships.

Initial estimates projected the drug could bring in $4 billion to $6 billion per year, and yield $120 million to $300 million annually for NU.

In April 2003 Pfizer submitted pregabalin for approval to the European Agency for the Evaluation of Medicinal Products, Europe’s equivalent of the FDA.

Pfizer planned to submit pregabalin to the FDA in December 2002 but was forced to conduct further research because tumors appeared in a certain species of mice during drug trials.

Although Silverman said he doesn’t receive frequent updates on the status of the drug he created, he said he hopes the drug can be marketed quickly to help those who suffer from various conditions and illnesses.

“I’m very excited about the prospect,” Silverman said. “I have seen publications about clinical trials and I hope (pregabalin) will help people with problems that no other drugs have been able to help.”

Philip Mease, a rheumatology physician and clinical researcher at Swedish Medical Center in Seattle, said he has seen the drug work effectively with many of his patients. In many cases, it has a rapid and durable effect on pain and limits sleep disturbances and fatigue, he said.

“Of the medications that we either used or worked with in clinical trials, this is one of the most effective,” Mease said. “When we have a drug that isn’t habit forming but is effective in treating pain, it’s very exciting for us.”

One of Mease’s patients, 67-year-old Elizabeth Tross-Deamer said she can sleep for eight hours undisturbed now that she takes pregabalin for treatment of fibromyalgia, a condition causing bone and muscle pain and stiffness.

Before enrolling in the clinical research study, she said she always was sleep-deprived and in pain.

Tross-Deamer said she is grateful for Silverman’s work on pregabalin and hopes others can benefit from the drug soon.

“God bless his heart,” Tross-Deamer said.