NEW YORK (CNNMoney.com) -
A new treatment for hyperactive kids could come in the form of a skin patch, not a pill.
Noven Pharmaceutical, a Miami-based drug maker specializing in skin patches, is awaiting a regulatory decision on Methypatch, a transdermal treatment for attention-deficit hyperactivity disorder that it filed with the Food and Drug Administration.
An FDA advisory committee will vote on Friday whether to recommend approval of Methypatch for the treatment of ADHD. This is not the same thing as a final decision, but the FDA usually follows the advice of its expert advisory panels.
Noven (down $0.21 to $13.51, Research), which has several estrogen patches on the market, has a lot riding on the FDA's decision.
Michael Krensavage, analyst for Raymond James & Associates, estimated that approval from the FDA would push up Noven stock price by $8 a share, but a negative decision could shave $3 off the shares, which closed Wednesday at about $13.51 on Nasdaq.
"That's a bet we like," wrote Krensavage in a recent market report.
Krensavage upgraded Noven to "strong buy" on Sept. 30, two days after regulators refused to approve the company's generic version of a painkiller patch. The refusal triggered a 16 percent plunge in Noven stock, and prompting Krensavage's upgrade.
The failure of the generic pain patch leaves investors "paying little for the company's next potential product, a patch version of methylphenidate," Krensavage wrote. Methylphenidate is the active ingredient in Ritalin and Concerta, pills for attention deficit disorder, an estimated $1 billion market.
David Steinberg, analyst for Deutsche Bank North America, said he was "counting on 2-to-1 odds, in favor of a positive vote" from the advisory panel.
He said Methypatch has demonstrated in clinical trials that it is an effective drug, and could be used by children who have difficulty swallowing pills.
But Ken Trbovich of RBC Capital Markets, who rates Noven neutral, said Methypatch could have a tough time getting past the FDA because it does not offer any new medical benefit that would outweigh possible side effects.
"If there is any problem with safety risks, the panel is not likely to approve the product," said Trbovich, noting that the active compound, methylphenidate, is a controlled substance.
Methylphenidate, a stimulant affecting the nervous system, is the same compound used in Ritalin, which has been off-patent for many years, and Johnson & Johnson's (down $0.25 to $61.75, Research) Concerta. Novartis (down $0.41 to $52.40, Research) currently markets methylphenidate as an extended-release, once-daily pill under the brand name Ritalin LA.
Methylphenidate is sometimes abused for its euphoric effects, according to the National Institutes of Health, and abusers have been known to chop up the pills and snort them.
ADHD affects up to 5 percent of children in the United States, according to the National Institute of Health. Children with the disorder show patterns of increased activity, impulsive behavior and inattention.
To find out more about the risks associated with ADHD treatments, click here.