Oxytrol OTC Success Depends On Driving Behavioral Changes

Merck’s Oxytrol for Women could set the stage for other OTC switches indicated for chronic conditions, but the lifestyle changes recommended with the drug could be a hurdle. Oxytrol faces similar challenges to alli, another first-in-class switch with behavioral changes recommended.

Success for the Oxytrol for Women patch for overactive bladder will depend partly on Merck & Co. Inc. overcoming some of the target population’s likely hesitancy to make behavioral changes linked to its efficacy.

If Merck’s marketing succeeds, the first-in-class OTC switch Oxytrol for Women (transdermal 3.9 mg oxybutynin) could become a blueprint for future switches indicated for chronic conditions and carrying label recommendations for behavioral changes. Meanwhile, FDA is in the early stages of developing its nonprescription safe use regulatory extension initiative to expand the types of drugs considered for sale without a prescription by using innovative technology and conditions of safe use.

However, OTC Oxytrol faces similar challenges to alli (orlistat), another first-in-class switch with recommended behavioral changes, which were outlined in its label instructions. GlaxoSmithKline PLC has struggled with alli since its heavily promoted launch in 2007 as the only OTC weight-loss drug.

If OTC Oxytrol generates sales as disappointing as alli’s, it would be another example of overestimating consumers’ willingness to do more than take a drug and expect results.

Merck's first-in-class OTC switch Oxytrol for Women, indicated for overactive bladder.

Image courtesy of Merck & Co. Inc.

“Will the patch be effective enough for most patients? That’s a big question,” says Rx-to-OTC switch consultant Steven Francesco.

In addition to educating consumers about an OTC solution for their symptoms, Merck must help them change their lifestyles to get the best results.

“From there, the questions are: How much is it really helping? And is it worth the price?” says Francesco, who operates Monmouth Beach, N.J.-based Francesco International.

Whitehouse Station, N.J.-based Merck licensed Oxytrol’s OTC rights from Allergan PLC Actavis continues marketing Oxytrol Rx to men, for whom diagnosing OAB is more complicated.

Lifestyle Modification Challenges

Information on Oxytrol for Women’s website and on package inserts advises users to follow a “lifestyle modification plan” as part of their treatment. The lifestyle changes include doing pelvic exercises, practicing timed voiding and urge suppression, keeping a bladder diary and in some cases restricting diets and reducing liquid intake at night.

Experts say doctors already recommend those measures for OAB patients, but many do not adhere to the regimen. This pattern highlights one of Merck’s challenges: convincing women who experience urgency and incontinence yet have not already adopted the regimen to start it when they use Oxytrol.

Tomas Griebling, a physician and urology department vice chairman at the University of Kansas Medical Center, said from his experience prescribing Oxytrol for women, the OTC product “may work for patients who are motivated.”

“They may be able to try it and get an improvement,” Griebling added, but cautioned that even patients who follow the recommended regimen often lapse once they see an improvement. “It’s different for every patient.”

Although the products are for different indications and require different behavioral changes, Oxytrol’s marketplace challenge is illustrated by alli’s story.

GSK can attest from its experience with alli that expecting users to change behavior is a tall order. Alli labeling instructs users to adjust their diets to avoid gas and fecal incontinence, and increase physical activity before they start taking the drug.

After impressive sales following its launch, alli sales slowed steadily as consumers in the target population either tried the product without success because they did not change behaviors, or opted not to use it because of the recommended changes.

According to data from market research firm IRI, for the 12-week period ending Oct. 6 alli’s U.S. sales fell 31.9% to $10.8 million, though the product makes GSK the No. 2 firm in the category, behind [Iovate Health Sciences Inc.]’s MuscleTech sports supplement brand. From multiple products, MuscleTech showed 26.3% growth to $16.03 million in sales during the period.

Chicago-based IRI’s data from U.S. multi-outlet grocery and drug stores, mass market retailers, military commissaries and some club and discount chains also show alli sales for the previous 52 weeks were up 12.6% to $56.1 million as the entire weight-loss category grew 21.1% to $507.8 million.

Glaxo included alli in a list of OTC brands it offered to divest in 2012. However, after firms showed interest in all the other OTC brands on the block but not alli, GSK decided to keep the product and to “rebuild that brand in a more focused way” (Also see "Glaxo "Shakes Up" Alli Ad Strategy With New Agency" - Pink Sheet, 29 Jun, 2009.).

Oxytrol Positives

Experts say most consumers are not willing to make necessary adjustments to achieve significant weight loss – if they could, they would not need alli.

Some point out, though, different factors influence whether a consumer will succeed with Oxytrol for Women, arguing the product has a chance to exceed alli’s performance in the marketplace. For one, effects from alli likely are less tolerable than Oxytrol’s most common side effects of dry mouth, constipation and site irritation.

“The challenge for drugs like alli is that behavior change required for long-term goals is not rewarded with short-term benefits. And sometimes, the behavioral change needs to be tailored,” said Joe McGovern, of consultancy Everything Health in New York.

With Oxytrol, though, benefits can come much sooner, typically within a couple of weeks, and there is less need to individualize the lifestyle changes among different consumers. While some patients will need to adjust their diets and evening fluid intake, most will do well as long as they regiment their voiding and do bladder exercises, McGovern said.

“The drug, plus support, should provide patients relief from distressing symptoms,” he said.

The pricing seems appealing. An eight-patch box retails for under $30, compared to $320 for the same number of Rx Oxytrol tablets. Merck also is making $3 discount coupons widely available. The product is marketed in boxes of four and as a single four-day patch.

“A lot of manufacturers make the mistake of getting greedy” in OTC switch pricing. “This looks reasonable,” Francesco says.

Pent-Up Demand

Merck is betting OTC Oxytrol will prompt many of the nation’s 20 million women with OAB symptoms into starting to better manage their own care. The firm says OAB in men and women causes $35 billion in spending annually, in both direct and indirect costs, including doctor visits and accessories such as panty liners and pads in addition to Rx drugs.

Oxytrol has commanded only a fraction of the approximately $1.3 billion Rx OAB product market and its sales were slipping prior to the switch. Some analysts, however, say it has better potential as an OTC (Also see "Merck’s Oxytrol Could Go From Rx Also-Ran To OTC Star – Analysts" - Pink Sheet, 10 Sep, 2012.).

“I think this switch is long overdue,” Francesco says.

And Merck says many women with OAB often are overdue for a diagnosis.

“Women who suffer from OAB wait on average more than three years before seeking care,” said urologist Eman Elkadry in the firm’s Sept. 25 release announcing the launch. Elkadry is a clinical instructor at Harvard Medical School and a clinician at Boston Urogynecology Associates at Mount Auburn Hospital in Cambridge, Mass.

“A lot of people have trouble if they wait too long,” Griebling said.

Tom Hayes, a managing partner at Westport, Conn.-based New England Consulting Group, expects doctors’ opinions of the product to play an important role in its uptake. About 8 million people, including 6.5 million women, in the U.S. are buying incontinence products, he said.

“People who have incontinence often suffer from multiple other disease states. They are probably in the doctor’s office a lot, so they may start asking about Oxytrol,” said Hayes, whose experience includes advising Pfizer Inc. and Procter & Gamble Co. on marketing.

Consumer Reports, he noted, gave a fairly negative review of Oxytrol in a January 2013 article, which highlighted its side effects and limited efficacy.

While Oxytrol for Women is an Rx-to-OTC switch and all oxybutynin tablet products remain prescription only, the drug’s heritage has not been a facet of its marketing. Hayes said he is “a little surprised I’m not seeing lots of claims that this product is ‘prescription strength,’ as that’s very important during the initial period of a switch.”

FDA: No Safety Signals

The patch has a lower oxybutynin dose than Rx tablets and causes fewer and less severe side effects, said Bill Soller, a self-care expert who conducted an extensive review of this class of drugs.

Soller, who heads the SollerPhD consultancy in Houston and is a faculty member at the University of California, San Francisco, School of Pharmacy, noted Merck’s switch proposal included study data that show fairly low rates of irritation among Oxytrol patch users.

The firm provided data to FDA showing 21.5% of women reported skin irritation events, including about 17% who specifically reported application site irritation, and that about 9% discontinued use of the patch due to skin irritation.

The switch was approved in January 2013 despite concerns from some members of a Nonprescription Drugs Advisory Committee about results from Merck’s actual use study. Data from the study suggested almost 80% of consumers would try the drug even if, according to the labeling instructions, they should consult a doctor first (Also see "Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch" - Pink Sheet, 28 Jan, 2013.).

However, FDA said the study revealed no safety signals, including delayed diagnoses of more serious conditions. The product label instructs women to use the drug only after experiencing symptoms for at least three months and to see a doctor if their symptoms worsen or do not improve after two weeks.

The firm also has listed other, more serious, diseases with similar symptoms, on the label. Merck argues that making the drug OTC could actually lead to earlier diagnoses of serious conditions, improving public health, as women become more aware of what their symptoms may signify.

The product website and a leaflet in the packaging include educational materials about overactive bladder.

Media: First Look

The marketing campaign includes three brief YouTube infomercials and television and online spots.

The actress in the TV spot appears confident as a sea of words floating around her reminds viewers of the many inconveniences overactive bladder sufferers face, including bathroom accidents, rushing and worry. Notably, the actress is wearing form-fitting white jeans instead of shapeless dark clothing, a practice Merck notes is among the “coping strategies” many women with incontinence use “to manage their condition.”

Merck representatives declined to elaborate on all the ways the company intends to engage the target market. At the product website, consumers can register for news and coupons.

The company has skipped building a Facebook page and Twitter account for Oxytrol. After the launch, many of the initial mentions of the product on Twitter poked fun at a person the tweeters claimed “needs Oxytrol.” While consumers might remember the ads and understand the content, the product is also a tempting punch line.

The symptoms obviously are serious to OAB sufferers and, if Merck is right, consumers will find the benefits of Oxytrol outweigh any inconvenience from making changes stated on the label.

[This story was contributed by “The Tan Sheet,” which provides in-depth coverage of OTC drugs, including Rx-to-OTC switches.]