Bayer HealthCare LLC waited to launch Aleve PM, the first OTC to combine naproxen for pain relief and diphenhydramine as a sleep aid, until FDA approved labeling for a 160-count package, seven months after the agency approved the product.

The Bayer AG business on Sept. 15 announced Aleve PM (naproxen sodium 220mg and diphenhydramine hydrochloride 25mg) is available at retailers across the U.S. The product, taken in two-caplet doses before sleeping, is indicated for adults and children 12 years and older to provide relief from occasional sleeplessness associated with minor aches and pains.

"Pain can not only delay the onset of sleep, it can cause frequent or early morning awakenings and prevent restful sleep. With Aleve PM, consumers can now benefit from the 12-hour pain-relieving strength of Aleve plus a good night's sleep for a better morning,” Laura Schwieterman, Bayer HealthCare’s brand director for Aleve, said in the firm’s release.

Aleve PM is available in 20-, 40-, 80- and 160-count packages.

Image courtesy of Bayer HealthCare LLC

According to the firm, the launch is supported by national advertising, print advertisements and consumer, digital and trade promotions centered around the theme, “Aleve PM for a Better AM.”

FDA approved Bayer HealthCare’s new drug application for Aleve PM in a Jan. 17 letter.

The Whipanny, N.J.-based firm submitted the NDA in March 2013 and provided FDA with additional information for the application in April, May, July, August, September, November and December that year and in January this year.

While diphenhydramine hydrochloride is included in multiple OTC monographs including nighttime sleep aid, naproxen is approved for OTC use through the NDA process and the firm needed another NDA approval to market a product that combines the ingredients.

According to the product website, Aleve PM is available in 20-, 40-, 80- and 160-count packages.

Labeling for the 160-count package, which is a carton with two 80-count containers, was submitted in a supplemental NDA in March. The sNDA was amended in April and approved in an Aug. 28 letter, according to FDA’s Orange Book website.

A Bayer HealthCare spokeswoman said the firm is marketing the 160-count package in club stores.

“This new count size required the carton labeling be submitted as a prior approval supplement and then reviewed and approved by FDA before it can be marketed,” she said in an email.

The suggested retail price for a 40-count package available online is $13.99 and for an 80-count is $15.99.

While Aleve PM is the first OTC naproxen/diphenhydramine combination, the product enters a crowded market for analgesics formulated with a sleep aid.

The market includes Pfizer Inc.’s Advil PM (ibuprofen 200mg/ diphenhydramine HCL 25mg); Johnson & Johnson/McNeil Consumer Healthcare’s Motrin PM (ibuprofen 200mg/diphenhydramine citrate 38mg); and private label versions of those and other brands. McNeil’s Tylenol PM is off the market temporarily as the firm prepares to re-launch the product after a recall and a manufacturing shutdown required in a consent decree.

No other OTC naproxen/diphenhydramine combinations are approved by FDA, but whether Aleve PM launches with marketing exclusivity could not be determined.

Aleve PM Enters Nighttime Pain-Relief Market After 160-Count Label Approved

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