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The switch to OTC of formerly Rx therapies expanded on the long-acting therapy model. For example, Aleve was first offered as a 12-hour OTC pain reliever in the mid1990s, and 12- and 24-hour forms of the low/non-sedating antihistamines Claritin, Zyrtec, and Allegra came to the OTC market in the early 2000s. Prilosec OTC is another Rx-to-OTC switch that offers 24-hour therapy.
Faster-acting products
Fast-acting products are becoming more important, especially for remedial products. For example, pain medicines that get into the system quicker for potentially faster relief are expanding. A good example is Advil Film-Coated tablets, which, according to the Advil website “goes to work in minutes” and “dissolves quickly and absorbs fast to stop pain before it gets worse”3.
More palatable products
The accelerated use of chewable gummies as a dose delivery format in the VMS space in the past 15 years has helped to expand the category and related brand franchises.
For example, Nature Made, the number one brand in the US market, has a broad presence in the dietary supplement market. The brand offers traditional tablets as well as gummies in a variety of forms, therapies, and sizes. While the gummies are likely targeted to bring in new consumers, the brand continues to offer tablets, which appeal to its traditional user base.
More consumer friendly products
Consumer friendliness relates to factors such as convenience, portability, and swallowability. For example, ODTs provide easier consumer dosing than traditional tablets, in many cases without requiring water. Portable forms such as thin films, lozenges, chewables, and mints, also provide an easy way to dose for consumers with “on-the-go” lifestyles.
Implementing a sound development and manufacturing process
To increase the likelihood of success, it’s critical to assemble the right team of both internal and external professionals, secure buy-in upfront, and ensure sound fiscal management.
Internal versus external development
Determine whether the company has the capability, capacity, time, and financial resources to develop a product with a new drug delivery system or whether the company should seek an external partner. If the company has the internal capability and owns or has access to intellectual property, developing the product internally will provide the most control and generally result in cost efficiencies, but it’s a good idea to evaluate external options.
Scouting activities at trade shows is a must, and being aware of what’s available may not only be important for a company’s own products, but may also provide a better understanding of what other companies are evaluating for their products. A broad review is good at the outset; then you can narrow and prioritize options once you understand what may appeal to your target user base, what is novel, and how quickly you can get the product to market.
First to market with novel solutions
The use of drug delivery supported by intellectual property protection is particularly important to justify consumer healthcare company investment, both in development activities as well as in post-launch marketing support. Patent protection and know-how are both assets marketers seek as they build their brands.
For example, when the H2 antagonist Pepcid was switched from Rx to OTC in 1995, the formulation had several years of patent protection remaining, allowing the Johnson & Johnson-Merck joint venture to invest in brand building and OTC marketing efforts. As a Johnson & Johnson brand, Pepcid built off of this platform to later introduce the chewable tablet, Pepcid Complete, which, according to the product website “combines an antacid that starts neutralizing acid in seconds with an H2 blocker that helps control acid all day or all night”4.
Case studies
Mucinex
Mucinex was launched by the Adams Respiratory Products organization and has been marketed by Reckitt Benckiser since 2009. Considered by many to be the OTC success story of the millennium, Mucinex was an estimated $10 million generic prescription medication before switching to OTC in 2002. It has since become a top 3 OTC powerhouse, with 2018 US sales in excess of $660 million. The brand used strong marketing efforts targeting both consumers and doctors and promoting a novel delivery mechanism (sustained-release tablets).
The brand has expanded to build its retail presence and appeal to consumers and healthcare professionals, and now includes formulations for chest congestion, cold & flu, sinus, cough, and children, and is available in a variety of forms, including tablets, liquid gels, powders, and liquids. The brand even offers combination forms for daytime and nighttime relief5. Each new formulation and dosage form has helped to grow the brand’s position as a market leader and expanded its footprint to a different type of consumer.
One-A-Day and Flintstones vitamins
The One-A-Day vitamin brand dates back to the 1940s, when it was first introduced as an oral tablet multiple vitamin to be administered on a daily basis. In the ensuing years, Miles, and later Bayer, expanded the One-A-Day brand footprint in order to appeal to a broader market. In 1968, Bayer licensed the Flintstones trademark and successfully established the Flintstones brand as a children’s vitamin product sold at retail to consumers6.
Over time, the Flintstones brand also expanded, and in 2005, the company began marketing an easy-to-take confectionery form—chewable gummies—which had broad appeal to its market. Within a few years, the One-A-Day brand began marketing a gummy form (One-A-Day VitaCraves), offering a “fun” way for adult consumers to take vitamins daily. The form helped transform the One-A-Day brand and increase its appeal. Over time, Bayer has expanded this business to a variety of subsegment user groups (including women, men, and teens) and has introduced additional products with broader indications (such as immunity support, energy, and heart health with omega 3). Bayer has also used the gummy format for its Phillips Colon Health probiotics.
The future of drug delivery
Projecting forward, oral consumer healthcare drug delivery growth will likely include easier-to-swallow tablets, better-tasting chewable and confectionery forms, and faster- and longer-acting forms. R&D efforts that can facilitate measurable therapy may be new goals that can be achieved with combinations of novel drug ingredients and new delivery systems. Finally, unit doses to ensure proper therapy will likely become greater factors for consumer health brands.
It will also be important to examine ongoing technology development and innovation in prescription medications as consumer healthcare companies focus on the future and building their brands. Smart technologies and custom-designed therapies, such as breakable pills and profile doses may impact the future development and use of OTC products.
Maintaining a consistent strategy will be key, and securing novel rather than “me too” solutions will be critical. Companies must carefully validate new technologies with consumer research and support them with awareness-building strategies. Developing or finding truly novel technologies will clearly be a challenge for innovation and new product efforts in the consumer healthcare space.
Avenues to help identify and secure novel technologies include delivery-specific conferences and seminars, targeted trade journals, university searches, patent screening, evaluating innovation in other related and unrelated industries, retail store checks, understanding ex-US innovation and brands, and internet searches. In-house innovation sessions with broad participation by professionals from a variety of disciplines can be a great way to find that next breakthrough technology. Marketers might identify the right external drug delivery “specialist” or “scout” to help support their growth initiatives. The market will be competitive, but there will be many opportunities to succeed.
References
1. www.nibib.nih.gov
2. nicholashall.com/DB6
3. www.advil.com/advil-film-coated
4. Pepcid.com
5. Mucinex.com
6. Flintstonesvitamins.com
Bob Nissen is president of Nissen Consulting Group (908 419 9254, bobnissen@gmail.com). He has more than 30 years of marketing and business development experience in the OTC drug industry and held senior positions in the OTC divisions of Abbott Labs, Schering-Plough, and Novartis. Nissen has worked on numerous initiatives utilizing new drug delivery systems to expand OTC and VMS brand franchises, as well as Rx-to-OTC switches before and after launch, including Afrin, Coricidin, Lotrimin, and Lamisil. He began consulting in business development and new technology search in 2006. The author thanks Nicholas Hall & Company for providing US OTC industry and brand sales data. For further information on the company, please visit nicholashall.com.