Prescription asthma drugs on the brink of patent expiry could breathe new life into Rx-to-OTC switches, but not without fierce opposition from some health care providers.

The asthma category “is ripe for a switch” partly because it addresses a symptomatic condition that is easily self-diagnosed and disproportionately affects a medically underserved population for whom there are few OTC options – thus creating a medical need, argues Morris S. Whitcup, the chief research officer at ORC International.

A recent survey shows consumers are highly interested in nonprescription access to asthma drugs, he notes.

Two of the most desired drugs – Advair (fluticasone propionate/salmeterol) and Singulair (montelukast sodium) – will lose their patent exclusivity within a year, which could increase manufacturers’ interest in a potential switch.

However, Whitcup acknowledged, sponsors in this category must overcome substantial barriers, including showing FDA that health care providers still will be involved in treatment for the chronic condition, and that consumers will self-select appropriately and follow labeled instructions.

Asthma Patients Favor Switch

Consumer demand and brand awareness is a key ingredient in a successful switch, and currently is strong in the asthma category.

Whitcup explained eight out of 10 asthma sufferers ORC International surveyed in August said they were interested in prescription treatments switching OTC, with 32% specifically interested in switching GlaxoSmithKline’s Advair, which loses patent protection this month, and 29% interested in Merck’s Singulair, which loses exclusivity next August.

ORC International’s online survey included 556 consumers with 300 or more suffering asthma. The survey also explored consumer acceptance and openness to switches in the hypertension and high cholesterol categories.

“The notable level of interest in nonprescription products to treat asthma is probably due to” many asthma sufferers being “medically underserved, thus heightening their interest in nonprescription alternatives,” according to ORC International’s report.

The study found one in three asthma sufferers surveyed had not seen a physician about their condition in the past six months, compared to one in four with hypertension and high cholesterol.

OTC asthma treatment options are sparse. Primatene Mist currently is available, but its future is unclear because of an impending environmental regulatory change that will force its current formulation off the market at the end of the year (Also see "Armstrong Says FDA "Assured" OTC Access Of Reformulated Primatene Mist" - Pink Sheet, 28 September, 2009.).

Switching asthma products could give consumers more choices without making them pay first for a physician visit, but potential sponsors should note expense could remain a barrier.

“Asthma is far more prevalent in poor children than in other populations and they are most dependent on third party payment,” explained Marcus Milton Reidenberg, a professor of medicine, pharmacology and public health at Weill Cornell Medical College.

He cautioned that while OTC access would alleviate the costs of medical bills for physician visits, it likely also would stick this group with higher bills for the medicine because Medicaid and other insurers do not cover OTCs.

Therefore, one financial barrier could replace another if the insurance system does not change, Reidenberg added.

Thus, firms looking to enter the OTC asthma category would need to consider the price point carefully.

Armstrong Pharmaceuticals’ Primatene Mist sells OTC for $17.99 to $21.99 on drugstore.com. The website also lists one bottle of Rx 30 4mg chew tabs of Singulair for $166.91 and one Rx 12 gm inhaler of Advair HFA for $208.99.

Barriers To Switch

Cost is not the only barrier to a successful switch. FDA generally has stayed away from switching drugs for chronic ailments that require oversight by a health care provider.

Some experts oppose switching asthma drugs, including Leslie Hendeles, a professor of pharmacy and pediatrics at the University of Florida and a former member of FDA’s pulmonary allergy drug advisory committee.

Asthma is a chronic condition and “is not a disease that is appropriate for self-management, especially since there are 5,000 people who die from asthma each year,” said Hendeles.

Most asthma deaths occur when patients “haven’t sought medical care early enough,” he said. “They just suck on a quick reliever inhaler and it doesn’t treat the inflammation and they progressively get worse.”

Hendeles sees “no chance in hell” Advair would switch OTC because it is only indicated for moderate to severe asthma and is expensive.

An advisory committee also likely would not switch Singulair for asthma because even though it has a wide margin of safety and no side effects it is “not very effective” and “would be indicated for patients who need to take a maintenance medicine on a regular basis and they need to be under the care of a physician,” Hendeles said.

“On the other hand,” Hendeles said, “Singulair has approval for allergic rhinitis and it conceivably could be reasonable to be over the counter for nose symptoms, but not of asthma.”

Just because a drug treats a chronic condition does not automatically mean FDA will reject a switch application.

The switch of nonsteroidal anti-inflammatory drugs is an exception to the chronic rule, and how firms label the painkillers could provide a blueprint for how asthma drugs could overcome a chronic use barrier.

“Nonsteroidals are certainly taken chronically for arthritis … [and] at the time when the switch issue was raised, there were enormous concerns about a lot more GI bleeding, all sorts of side effects and while they are certainly occurring, they are not sufficient that anybody is asking for them to be put back to Rx-only,” Reidenberg said.

He added, “Apparently they are being safely used.”

The label for Tylenol Arthritis Pain directs consumers to use the product for no more than 10 days unless directed by a physician, but Reidenberg says people often take the drug daily.

OTC asthma products could, and indeed already do, have similar directions. Primatene Mist directs users to see a doctor if they are not better in 20 minutes, get worse, need 12 inhalations in a day, use more than nine inhalations a day for more than three days a week or have more than two asthma attacks in a week.

Data presented at an FDA workshop in 2009 revealed consumers appropriately used Primatene Mist, “and unless somebody has important evidence to the contrary, I don’t see any reason why you can’t have equivalents over the counter. I personally think that people would buy inhaled steroids if they were over the counter to continue medication a physician prescribes or advises,” Reidenberg said.

Singulair and Advair present different challenges from Primatene Mist because they are different drugs, Hendeles said.

Sale Requirements Could Ease Switches

Emerging technology and evolving pharmacy-customer relations could facilitate an asthma drug switch by helping ensure a consumer sees a physician before buying an OTC asthma drug, Whitcup said.

One option would be to place asthma products behind the counter or require consumers to pick up the drug from an in-store clinic. Both options would enable pharmacists, nurses or nurse practitioners to discuss a consumer’s health prior to giving them the drug, he said.

Earlier this year, FDA drug center chief Janet Woodcock said firms volunteering to place drugs BTC could facilitate Rx-to-nonprescription switches (Also see "CDER Director Sees Behind-The-Counter Switches As Best Bet" - Pink Sheet, 11 April, 2011.).

Another option would be to require a health identification card that consumers could present to purchase asthma drugs OTC. The card could be scanned quickly to reveal whether and when the consumer visited a provider about asthma, Whitcup proposed.

He added 35% of the consumers ORC International surveyed about switches said they would be more interested in OTC products for asthma, hypertension or cholesterol management if they had such a health card.

By Elizabeth Crawford

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