Progressive Grocer

AUG 2015

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104 | Progressive Grocer | Ahead of What's Next | August 2015 Health Beauty & Wellness OTC Medications are adding space for new entries by reducing the space devoted to cough drops, "making outliers a play" and moving children's formulas to a pediatric section. Te digestive health segment has also seen signifcant Rx-to-OTC switch action. Te introduction of Pfzer's switched Nexium 24HR in 2014 was the latest in a stream of proton pump inhibitor (PPI) switches. "Te PPIs have re- ally changed that category," afrms Wendland. "Some of these products are approved for insur- ance reimbursement, and older, more traditional products have taken a huge hit." "When Nexium switched, it was big news," says IRI's Buono. "Te 'purple pill' is so well known that it will be difcult for newer switches to gain traction." Kline research shows that private label products represent 21 percent of all antacid sales and private label products represent half of all sales in the PPI segment of the category, largely due to the higher price tag of PPI products. Not all switched products have been able to fnd an audience, however. Kenilworth, N.J.-based Merck's Oxytrol for Women transdermal patch for the treatment of overactive bladder, which switched in 2013, has been discontinued. "Sales were disap- pointing for a frst-of-its-kind product like this, but customers may have had a hard time fnding the product on store shelves, since it was often posi- tioned near feminine hygiene, and the transdermal patch delivery may not have been optimal for some consumers," notes Mahecha. Statins on OTC Horizon? Upcoming switch candidates will have some hur- dles to overcome, even as the FDA adopts a new paradigm for Rx-to-OTC transitions. Citing the large public health impact of the under-treatment of common diseases and conditions in increased cost and sufering, the FDA has launched the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, which will allow the agency to explore how health care professionals and in- novative technologies can contribute to the safe use of drugs in a nonprescription setting. Hyperten- sion and chronic obstructive pulmonary disease (COPD) are two conditions on the FDA's radar. "Te FDA has sent a letter to the pharma industry stating that it is open to new indications for switches, and the agency is positioned to be less conservative than it has been in the past," says Mahecha. Tis could mean that prescription drugs once considered poor candidates for a switch could possibly get a green light. Rye Brook, N.Y.-based Pfzer will likely seek a switch for the erectile dysfunction (ED) drug Viagra. Because of concerns regarding a danger- ous drop in blood pressure that can occur when men with pre-existing heart conditions use the medication, the ability for consumers to self-select must be proved before the FDA will consider a switch. ED can also be a symptom of other seri- ous health conditions, so patients would need to rule out other diseases before using the drugs. Recreational use by consumers who don't qualify for ED drugs is also a potential problem. A switch for cholesterol-lowering statin drugs would depend on how patients can be monitored once they begin using the drugs. Kiosks, apps and human interaction in the form of a pharma- cist could help get tricky switches the go-ahead from the FDA. "We know that Pfzer is on record for pursuing a switch of the cholesterol-lowering statin Lipitor," notes David Spangler, SVP, policy, and general counsel and secretary at the Washington, D.C.- based Consumer Healthcare Products Association (CHPA). "Others have tried and not made it over the fnish line before, but if they have the right data, they may get approval." "Merck 's Mevacor has been denied a switch three times and Bristol-Myers Squibb's Pravachol was also denied. High cholesterol is a complex [condition] to manage, but Pfzer is putting a lot of money behind the push for a switch and will likely plan to use technology that wasn't avail- able when the other switch applications were being considered," says Mahecha. "If statins are switched, all bets are of as to what other classes of drugs can be switched as well." Further Switches Ahead Other categories likely to see switches are migraine medications and sleep aids. "Sleep issues are almost an epidemic in our culture," asserts Buono. "Prod- ucts that don't represent major safety concerns are likely to see a switch." Mahecha expects Japanese pharmaceutical company Takeda's Rozerem to be a likely switch candidate in the sleep aid segment. "With sleep aids as one of the fastest-growing categories, there are several products likely to be considered for a switch," agrees Wendland. "Te challenge will be to create a totally new section that really addresses sleep aids. I'd like to see a 4-foot section that would include branded and private label products alongside eye masks, ambient music ma- chines and products for restless leg syndrome." PG Learn more about Rx-to-OTC switches at

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