US Pharm. 2007;32(7)(OTC suppl):22.

First OTC Weight Loss Drug Now Available in Stores
GlaxoSmithKline's alli (orlistat), the only FDA-approved weight loss product, recently hit shelves in pharmacies, grocery stores, and mass merchandisers nationwide. alli was approved as an OTC product in February.

"alli is not for people looking for miracle pills and overnight results. It offers consumers a proven, safe, OTC option to help them lose weight gradually," said Steven L. Burton, Vice President of Weight Control at GlaxoSmithKline Consumer Healthcare. alli is intended for use in conjunction with diet and exercise and has been reported to help people lose 50% more weight than with dieting alone. 

Once Popular OTC Contraceptive Product to Relaunch
Today Sponge, a hormone-free OTC contraceptive option for women, will relaunch this summer with a new package design. Today Sponge measures only 1.75 inches in diameter and .50 inches in thickness and fits comfortably over the cervix. The product prevents pregnancy for 24 hours by blocking the entry of sperm into the cervix, continuously releasing the spermicide nonoxynol 9, and absorbing sperm in the foam sponge; it has been proven to be 89% to 91% effective in preventing pregnancy. Today Sponge will be available in major chain drug stores, as well as in Target, Wal-Mart, and select grocery stores.

FDA Approves New OTC Nicotine Gum Products
The Perrigo Company has received FDA approval to market OTC coated fruit nicotine polacrilex gum USP, 2 mg and 4 mg, as an aid to smoking cessation. The product will be marketed under store brand names and is expected to be available in early 2008.

The FDA has also granted approval of Novartis Consumer Health's Thrive (nicotine polacrilex gum USP, 2 mg and 4 mg) to help smokers quit in 12 weeks. The mint-flavored gum will be available as an OTC product nationwide in late 2007.

MiraLax Receives OTC Status
Schering-Plough announced that prescription-strength MiraLax (polyethylene glycol 3350) is now available as an OTC treatment for occasional constipation, making it the first laxative to switch from prescription to OTC status in the past 30 years.

MiraLax is taken once daily and comes in the form of a powder, which dissolves completely in any beverage (e.g., coffee, tea, juice, soda). The product works by increasing the frequency of bowel movements without causing unwanted side effects such as cramps and gas.

Prescription/OTC Pain Medications Do Not Prevent AD
The OTC pain medication naproxen and the prescription pain reliever celecoxib do not prevent Alzheimer's disease, according to a study in the online edition of Neurology. These findings contradict earlier studies, which found that sustained use of NSAIDs may have protective effects against Alzheimer's disease.

More than 2,100 people older than 70, who had no signs of dementia but who had a family history of Alzheimer's disease, received daily doses of either naproxen, celecoxib, or placebo for up to four years; most participants received treatment for less than two years. The study found that neither drug was associated with the prevention of Alzheimer's disease or dementia.

One explanation for the inconsistency in these findings, compared with those of other studies, may be that the findings of the current study relate specifically to celecoxib and naproxen but not to other commonly used NSAIDs, said the researchers. Another explanation may be that the drugs might not prevent the progression of the disease in people with advanced Alzheimer's disease pathology who are asymptomatic.

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