FDA Approves Lactose-Free Formulation of Antispasmodic/Anticholinergic, Pamine (Methoscopolamine)
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FDA Approves Lactose-Free Formulation of Antispasmodic/Anticholinergic, Pamine (Methoscopolamine)

FAIRFIELD, NJ -- June 28, 2001 -- Bradley Pharmaceuticals, Inc. announced today that the Food and Drug Administration (FDA) approved a lactose-free formulation of Pamine® (methscopolamine bromide), the company's fast-growing antispasmodic/anticholinergic therapy.

Although the original Pamine formula contained only a very small amount of lactose that would not have adversely affected most lactose-intolerant patients, Bradley chose to create this new formulation to ensure that this therapy was the best possible product.

In a recent survey, gastroenterologists estimate that 10 to 40 percent of their patients with gastrointestinal (GI) hypermotility are lactose-intolerant. It is estimated that between 30 and 50 million Americans are lactose-intolerant, and some studies report that incidences of lactose intolerance are very high in certain ethnic populations. According to these reports, as many as 75 percent of African-Americans and 90 percent of Asians may be lactose-intolerant.

Daniel Glassman, President and CEO of Bradley Pharmaceuticals, Inc., stated, "We have improved the formulation of Pamine because we recognize the special needs of lactose-intolerant patients. Our goal is to reduce the possibility of lactose interfering with the relief Pamine can provide. New and improved Pamine offers lactose-intolerant patients the safest and most effective antispasmodic/anticholinergic that we can make."

SOURCE: Bradley Pharmaceuticals, Inc.

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