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Executive Summary

Fison's nonbronchodilating agent Tilade (nedocromil) should be approved for the treatment of asthma, FDA's Pulmonary-Allergy Drugs Advisory Committee recommended by a five-to-one vote on June 11. Three committee members abstained from the vote due to potential conflicts of interest. "It is relatively safe and we have very limited medication to use for asthmatics, so [nedocromil] can be approved," committee member Marjorie Lee, MD, stated in recommending approval. The two major studies presented by Fisons in support of the Tilade NDA showed statistically significant improvements in pulmonary function, daytime asthma, and nighttime asthma in patients treated with 16 mg/day nedocromil compared to placebo. One study of 121 patients looked at the effects of 4 mg nedocromil four times daily in mild-to-moderate asthmatics on maintenance bronchodilator treatment. The study found an initial improvement in pulmonary function (FEV1) in the nedocromil patient group and a statistically significant improvement in symptoms within three days. The improvement in FEV1 continued after treatment with theophylline and oral beta-2 agonists was discontinued. The second study presented to the committee compared nedocromil to Fisons' Intal (cromolyn sodium) and placebo and included 100 patients in each treatment arm. Improvements in pulmonary function occurred over the first two weeks of nedocromil administration, and symptoms associated with daytime and nighttime asthma were significantly reduced in the nedocromil group compared to placebo. However, in all parameters "the differences between the [Intal and Tilade] treatments were clinically insignificant," Fisons Medical Director Richard Foulds, MD, pointed out. The most common adverse reaction seen in the studies was a bad after taste, occurring in 13% of patients, with headaches, nausea and rhinitis reported in a small percentage of the patients. * While most committee members agreed that nedocromil demonstrated efficacy when compared to placebo, several committee members characterized the clinical data as being less than conclusive. "The data is soft. The symptom scores are soft generally," commented Joann Blessing-Moore, MD, Stanford Medical Center. However, in terms of bronchohyperreactivity and pulmonary function data, Blessing-More suggested that "the data does look better than placebo." FDA medical reviewer Sherwin Straus, MD, criticized the studies presented by Fisons, asserting that "all these studies border on insignificance." Straus indicated that he found it problematic that the study data contained a few outliers that seemed to skew the results. "When we removed the questionable patients, the statistical significance was lost," Straus said. Of the trial comparing nedocromil and cromolyn sodium, Straus remarked that nedocromil "is sandwiched in between everyone, with Intal being the best and placebo being the the worst." He observed that Intal's superiority over Tilade "reaches statistical significance for nighttime asthma and also for FEV1 at the 3% level." Citing questions about the statistical strength of the data and nedocromil's relative efficacy compared to cromolyn sodium, Lee suggested that nedocromil "is not a first line drug of choice." FDA Office of Drug Evaluation I Deputy Director Paula Botstein, MD, pointed out: "If something beats placebo, we would be obliged to approve it."

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