A Procter & Gamble Co. toothbrush with Bluetooth connectivity to a smartphone app programmed to prompt better brushing offers a glimpse of the kind of technology likely to support some future Rx-to-OTC switches.

The same tools that can direct consumer brushing behavior could potentially be applied to improving or dialing in dosing behavior of consumers self-treating for chronic conditions.

Oral B SmartSeries 7000 connects to an Oral B smartphone app using Bluetooth 4.0, helping a brusher to “guide more effective and efficient brushing,” P&G CEO A.G. Lafley said during P&G's presentation at the Consumer Analyst Conference of New York Feb. 20.

Poised to “set a new standard in personal oral care,” the toothbrush connects to the app to provide real-time guidance while a person brushes, and “records brushing activity as data that you can chart on your own and share with dental professionals, helping to create smarter and more personalized brushing routines,” P&G noted in a Feb. 21 release.

P&G’s Oral B SmartSeries 7000 toothbrush connects to an Oral B smartphone app, for real-time guidance on brushing, using Bluetooth 4.0.

Image courtesy of Procter & Gamble Co. Inc.

NCI Consulting President Susan Lavine Coleman, who consults with companies pursuing OTC drug switches, sees the product and app as a good example of the types of creative proposals FDA is encouraging drug companies to make in OTC switch applications.

“This is exactly the kind of thing that FDA was thinking about for the [Nonprescription Safe Use Regulation Expansion] initiative,” she said in an interview. “There are a range of different applications where you could use connectivity to affect consumer behavior, education and health monitoring,” when it comes to drug dosing, she added.

FDA presented its drug expansion initiative – known as NSURE – in a February 2012 Federal Register notice. The agency characterizes the effort as the development of a new paradigm for drug sponsors that would foster providing nonprescription access to some categories of drugs that treat chronic conditions, an area in which patients often struggle to comply with daily dosage requirements Also see "FDA Digs Deeper On “New Paradigm” To Expand Rx Switches" - Pink Sheet, 5 March, 2012..

Through NSURE, FDA has encouraged companies to move forward with creative switch applications prior to its publishing a guidance document on its expanded drug approval initiative. Such proposals could include mobile applications that make it easy for consumers to track dosing, take drugs on time and communicate with physicians, Lavine Coleman said.

“For example, you can imagine connectivity, which is recording when the bottle [of medicine] is being opened, and you assess compliance with people every day,” she said, noting an app could even remind people when to take their drugs.

Multiple products in the potential Rx-to-OTC switch pipeline could require educational material, beyond the label, to guide consumers in safe self-selection and use.

“Devices like this are ways to help monitor compliance, but also reassure ourselves that consumers, without the regular input of physicians, are performing at least as well as they would in the Rx world,” Lavine Coleman said. She added that such technology could be particularly helpful to patients taking drugs daily to treat chronic conditions such as high blood pressure or diabetes.

With no standards yet set for including technology in an OTC switch application under NSURE, Lavine Coleman said apps could likely be incorporated into an OTC drug trial, to demonstrate real world behavior of a system.

“Data-based Solutions”

Oral B SmartSeries 7000 was showcased at the Mobile World Congress in Barcelona Feb. 24, positioned there as an “essential element to the well-connected bathroom,” P&G stated in its release. The toothbrush will launch this spring in a limited rollout in Germany before distribution expands to the U.S. and other regions in the fall, according to the company.

Pre-tests of the app have shown brushing time increases from less than 60 seconds with a manual toothbrush to two minutes and 16 seconds, surpassing the dental professional-recommended two-minute per session brush.

P&G VP Global Oral Care Wayne Randall said the toothbrush “will have significant impact on the future of personal oral care, providing data-based solutions for oral health, and making the relationship between dental professionals and patients a more collaborative one.”

The toothbrush did not need pre-market approval from FDA’s device center because it is similar to other products already available, and as an accessory to the device the app did not need clearance from the agency, according to a P&G spokesperson.

In addition to Bluetooth connectivity, the toothbrush features six cleaning modes: daily cleaning, deep clean, whitening, gum care, sensitive and tongue cleaning. The toothbrush carries a suggested retail price of $219, according to P&G. Bluetooth technology eventually will be available in multiple Oral-B electric toothbrushes.

In 2013 Church & Dwight Co. Inc. expanded its Arm & Hammer Spinbrush power toothbrush line collection with Tooth Tunes toothbrushes that encourage longer brushing by playing music that is transferred to the inner ear by vibrations in the teeth and jaw ([A#05130617005]).

P&G Tech Toothbrush May Foretell OTC Switch Future

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