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Nicotine Inhaler Wins FDA Panel Backing

Kristin Jensen

December 13, 1996

c.1996 Bloomberg Business News BETHESDA, Md. -- Pharmacia & Upjohn Inc.'s new nicotine inhaler has won the backing of a Food and Drug Administration advisory panel to help smokers who want to kick the habit.

The panel's action Friday came after FDA reviewers told the panel they were convinced of the safety and effectiveness of the product as a stop-smoking aid and urged the panel to recommend it for agency approval. The FDA typically follows the advice of its expert committees.

"I think it's effective,'' said Max Schneider, panel chairman and a doctor practicing in Orange, California. He said he's in favor of "anything I can do to get patients to quit, and I do think this is probably an effective product.'' In two unanimous votes, the panel said the product is safe and effective enough for marketing as a stop-smoking aid. Panel members said, though, they want the company to package the product carefully so that children can't get hold of the nicotine.

If approved, Johnson & Johnson's McNeil Consumer Products unit will market the inhaler. Earlier Friday, Pharmacia & Upjohn officials told the panel that its Nicotrol inhaler is the first nicotine replacement therapy that addresses the urge for nicotine as well as the physical urges that drive smokers to put a cigarette in their mouths and puff, officials said. That's key for some smokers who aren't able to quit using currently available nicotine patches and gum, the company said.

"They complain that they are missing their cigarettes,'' said Karl Olov Fagerstrom, the company's director of scientific information for nicotine replacement therapy. The inhaler, he said, "addresses the behavioral and sensory components that no other system does.'' Company officials presented studies to the FDA advisory panel today that showed its Nicotrol inhaler could improve quit rates at one year -- 6 months after stopping inhaler use -- by about twice that of a placebo therapy. That's about as effective as nicotine patches have proved in past studies, though the company said the inhaler itself works better for smokers more interested in the physical sensation.

The Nicotrol inhaler is a plastic mouthpiece with a nicotine "plug.'' It allows smokers to inhale vaporized nicotine and satisfy their urge for an oral "smoke'' while giving them a total of only about one-third of the nicotine in a cigarette. In addition, while it takes smokers about 10 puffs of a cigarette to inhale 1 mg of nicotine, the inhaler requires between 70 and 80 puffs, the company said.

Most people in the clinical studies used about six cartridges a day for the first 6 weeks, the company said. Patients used the inhalers for 3 months, then gradually reduced their use for another three months before ending therapy.

After one year, between 11 and 13 percent of patients in the company's two major trials still weren't smoking six months after stopping inhaler use, compared to between 5 percent and 10 percent of patients on placebo, researchers said.

The company overcame FDA and panel member concerns that the device looked too much like a cigarette. Panel members said they were convinced by the inhaler's benefits though they originally found the similarities "disturbing.'' Pharmacia & Upjohn officials insisted the device is more than a smokeless, tar-less cigarette. The nicotine is absorbed through the mouth and not into the lungs, and the device helps lower nicotine levels and encourages smokers to quit.

About 40 percent of patients experienced some side effects such as cough and irritation though they were about as severe as side effects from the placebo therapy, the company said. The inhaler also has a low potential for abuse, the company said.

The amount of nicotine per puff can be affected by temperature, the company said. Cold weather can cause a user to get little or no nicotine per puff while warmer weather can cause higher doses, the company said. If the prescription Nicotrol inhaler is approved, it faces an uphill battle in the $250 million smoking cessation market currently dominated by nicotine patches and gum available over the counter, analysts said before the hearing.

SmithKline Beecham Consumer Healthcare Corp.'s NicoDerm CQ patch, developed by Hoechst AG and Alza Corp., won FDA approval for OTC use in August, while Pharmacia & Upjohn's Nicotrol patch, marketed by Johnson & Johnson's McNeil Consumer Products unit, won OTC approval in July. Earlier in the year, SmithKline also won OTC approval for its Nicorette gum.

In addition, the same panel Thursday said Glaxo Wellcome Plc's anti-depression drug Wellbutrin is safe and effective for use as the first non-nicotine, stop-smoking therapy, thereby backing its approval. The tablets, though, would also be prescription-only. McNeil also markets a prescription-only nicotine nasal spray developed by Pharmacia & Upjohn. The companies' Nicotrol inhaler is already approved in Denmark, Sweden and Italy for over-the-counter use as well as prescription use in the Netherlands.

About 16 million Americans try to quit smoking each year --and about 14 million of them fail. The government blames the smoking habit for an estimated 400,000 deaths a year.