Earlier this year, the FDA approved three products for nonprescription use - Voltaren^® Arthritis Pain (diclofenac sodium topical gel, 1%), Pataday^® Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%), and Pataday^® Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%). All three of these products were originally available as prescription products and are now available over the counter (OTC) in the United States.

These approvals indicate an overall trend arising with the US FDA – a push to make a broader range of nonprescription drugs available to consumers over the counter. This shift suggests a desire from the agency to empower patients and potentially lower the financial burden of unnecessary doctor's visits on the healthcare system. One way in which OTC products are being made more available is through the rise of Rx-to-OTC switches.

More than 700 products have made the switch from Rx to OTC over the past several decades, but recent years have seen an upswing. An Rx-to-OTC switch describes the process by which an approved prescription (Rx) drug product acquires nonprescription, OTC status in the United States. In this scenario, a product is first marketed as a prescription product.

After an appropriate amount of time has gone by, the manufacturer may wish to pursue OTC status for the product and submit a new application to the FDA. The administration will then review the application. New studies may be required if a new indication is proposed or if the target patient population is different. It is important to translate the prescription label into consumer-friendly terms. Additional consumer studies may be required to determine if use instructions are clear and the patient can self-administer the drug.

Global Market Insights has predicted a 5.5% compound annual growth rate (CAGR) for global OTC drug sales between 2019 and 2024, with Rx-to-OTC switches being a primary contributor. This growth should come as no surprise with the FDA indicating a willingness to work with industry on expanding OTC options. As a result, more companies will inevitably look to employ Rx-to-OTC switches to derive additional value from their key products. In this blog post, LLS Health discusses growth drivers in Rx-to-OTC switches, the benefits of converting a product to OTC, and how patient considerations are shaping product development.

What's driving Rx-to-OTC switches?

There are several reasons a company may wish to switch from Rx to OTC, but life cycle extension is the most common. When a branded pharmaceutical product approaches patent expiration, it often faces significant competition from generic manufacturers. This competition will inevitably decrease product profits unless the manufacturer takes other measures.

There are multiple strategies a manufacturer can use to prolong a product's lifespan. These could include:

Altering a product's formulation (ex. creating an extended-release version of the existing product)
Changing a product's delivery method/dosage form (ex. switching from an oral tablet to a drug-eluting implantable system)
Seeking approval for the product to treat a new indication

Many of these would involve a 505(b)(2) application if the manufacturer wanted to keep the product prescription, but still extend the exclusivity period and life cycle. A 505(b)(2) is a new drug application (NDA) that contains full safety and effectiveness data, like a standard 505(b)(1) NDA application, but allows some information required for approval to come from pre-existing studies for comparable product/s. 505(b)(2)s are often an attractive route for manufacturers; Lubrizol has witnessed this firsthand and has extensive experience supporting customers who pursue this regulatory pathway.

505(b)(2)s can also be used to enact an Rx-to-OTC switch, though this is not the only way to accomplish a switch. If the product does not meet existing OTC monograph requirements, an NDA is required to switch the product to OTC, which would fall under the 505(b)(1) or 505(b)(2) regulatory pathway.

For companies looking for a life cycle extension strategy that helps consumers take charge of their health, Rx-to-OTC is a viable and appealing option. Transitioning to an OTC model may help sustain target revenue and grow a product's lifetime value. The FDA typically grants 3-year exclusivity to products new to the OTC market. Additionally, companies that already have both a pharmaceutical and consumer health division, as many large ones do, can easily employ the Rx-to-OTC strategy. These companies already possess the commercial infrastructure required to successfully market an OTC product, furthering this route's attractiveness.

Importantly, Rx-to-OTC switches provide considerable advantages for patients, retailers, and the health economy at large, as well as manufacturers. Patients appreciate OTC medications' unique advantages, including lower overall costs and the ability to make treatment decisions without doctors and insurers. Retailers benefit from having more options on their shelves, especially if the product has prior brand recognition. Additionally, studies have found that OTC drug products potentially save healthcare systems billions of dollars. For every dollar spent on OTC products, the US healthcare system saves ~$6-7, equaling around $102 billion in savings in 2010 alone.

How do patients play a role?

In addition to life cycle extension, increased patient demand for OTC products provides a new and compelling incentive for companies to make the Rx-to-OTC switch. The industry will continue to grow as patients progressively desire more control over their health. Consumers are demanding more accessible and varied treatment options, as well as more consumer-friendly products.

Therefore, pharmaceutical manufacturers should be mindful of end-user considerations even in early development, especially if they are considering an Rx-to-OTC switch later. Failing to design a patient friendly product initially may result in lower sales or even the need for reformulation when a product is converted to OTC. Product options are already vast in the over-the-counter market; a product must be patient-centric to differentiate and gain patient acceptability. Product attributes such as convenience, comfortability, and administration ease should all be considered upfront to avoid unnecessary costs and challenges.

Choosing quality formulation components, such as excipients, plays an essential role in developing patient-centric products. With the right excipients, a manufacturer can create a product with targeted attributes that improve the patient experience. Examples include ingredients that enable better-feeling, easier-absorbing topical gels or smaller extended-release oral tablets that are easier to swallow. Excipients can also mask the taste of unpleasant tasting drugs, which is particularly important in pediatrics, and eliminate the need to "shake well before use" an oral liquid. Carbopol^® polymers are carbomer excipients that can enable these consumer-friendly qualities and more.

Voltaren^® Arthritis Pain Gel, one of the products approved for OTC use earlier this year, provides an excellent example of a patient-centric Rx-to-OTC switch product formulated with carbomer excipients. According to the Voltaren website, "thanks to the specialized Voltaren Emugel™ formulation, it's non-greasy..." This non-greasy attribute is one example of the product's enhanced consumer features, which is likely contributing to its success in the OTC market thus far.

What's the future of Rx-to-OTC switches?

Many drugs available only through a prescription in the United States are already available over-the-counter in other countries. An example would be topical erythromycin, which is Rx in the US but OTC in Belgium and Poland. Additionally, many indications in the US have limited to no OTC treatment options available, such as high cholesterol and irritable bowel syndrome, which is not the case in select European countries. These facts provide motivation and pressure for the US to continue to expand OTC treatment options and explore Rx-to-OTC switches, which will drive market growth.

As this industry continues to grow, pharmaceutical manufacturers should be increasingly mindful of the considerations mentioned in this post, particularly those that involve patients. Companies considering an Rx-to-OTC switch should help ensure their long-term success by considering patient-centricity early on. Choosing the proper product ingredients can be crucial in this respect.

LLS Health provides patient-centric pharmaceutical ingredients that meet established and emerging needs in the life sciences industry. Our Carbopol^® polymers are utilized in pharmaceutical products as rheology modifiers, tablet binders, suspension stabilizers, extended release polymers, and mucoadhesive aids, among others. Contact us today to learn more about how we support our partners through Rx-to-OTC switches.

Authors:

Gaurab Sengupta | Global Business Manager

Ashley M. Rein | Technical Marketing Specialist

Rx-to-OTC Switches: Growth, Drivers & The Role of Patients