Ro, a direct-to-consumer virtual health company, is diving into the weight management space with the launch of a new product offering aimed at helping patients shed the pounds.
Ro, best-known for its online platform that specializes in men’s health, is now going to be offering Plenity, a new weight management product. Plenity landed FDA clearance last April and is classified as a Class II Medical Device. The new offering was born out of a partnership between Ro and biotech company Gelesis, which makes the medication. According to the pair, Plenity helps users lose on average 22 pounds and about 10% of their body weight.
“We recognized and saw that in our current patient population, [excess weight] was an underlying cause to some of the conditions they originally came in for. We saw [we] could help them get at the root cause of their health challenges,” Zachariah Reitano, CEO and cofounder of Ro, told MobiHealthNews. “There are 150 million people in the US with a BMI between 25 and 40… a lot of them are unable to access care.”
Like Ro’s other offerings, patients interested in the service will be assessed through a telemedicine consultation with one of the company’s affiliated physicians. If appropriate, one of Ro’s doctors can prescribe Plenity. The service will be offered on both Roman, Ro’s platform for men’s health, and Rory, the company’s platform for female health. The aim of the pill is to increase a user’s feeling of fullness.
"Plenity is synthesized from two naturally derived ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine," David Pass, head of commercial and COO of Gelesis, told MobiHealthNews. "The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods (e.g., vegetables) without caloric value. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine, promoting satiety and fullness. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements (and are not absorbed)."
Users take three capsules before lunch and three more before dinner. After taking the capsules users are instructed to drink 16 ounces of water and then wait 20 minutes before having their next meal.
“One of the biggest challenge with trying to lose weight is deprivation, feeling hungry like you aren’t getting what foods your body needs and what Plenity does is it helps what you do work better. It is in addition to diet and exercise,” Pass said. “It really helps the patient lose more weight than they would otherwise on their own.”
The product is targeted at adults who have a body mass index of 25 to 40, which means its cleared for those who are overweight (BMI of 25 to 29) and most patients with obesity (BMI 30.0 and higher).
“Previously there really were no products at the lower end [for patients with a BMI] from 25 to 27, which is just mildly overweight, and then up to 30 they were really limited to patients having common risk factors,” Pass said. “So this meets a high unmet need.”
Reitano said this new offering fulfills the company’s aim to provide broader suite of services, and also to bring pharma treatments to market sooner.
“I think the reason why we are really excited is it is an opportunity for us to add more products and services that are more analogous to what someone would receive if they were visiting their primary care office,” Reitano said. “Second thing was seeing pharma companies excited about this additional element of distribution to increase access to new treatments faster.”
The new service is slated for sometime in 2020, although interested consumers can register for updates prior to the launch.
WHY IT MATTERS
According to the CDC, 71.6% of US adults over the age of 20 are overweight or obese. Obesity can put patients at risk for certain conditions including heart disease, stroke, Type 2 diabetes and certain types of cancers, according to the agency.
Ro is pitching this new offering as a way to help people access medication.
THE LARGER TREND
Ro got its start specializing in men’s sexual health and wellness. Since then it has launched Rory, a platform for women experiencing menopause. The company has also dipped into smoking cessation, with its platform Zero, which uses a prescription nicotine replacement therapy and behavioral app. The company is also particularly well funded. In 2018 it landed $85 million to work on Zero.
However, it hasn't been completely without controversy. Ro and its main competitor Hims, which also works in in the online mail-order sexual health space, came under fire when a New York Times article examined the company’s prescribing practices. The article points out that the clients come to the platforms with a “self-diagnosis” and don’t need to see a doctor in person.
ON THE RECORD
“Our goal is simple: create multiple options for consumers to access a healthcare professional wherever they feel most comfortable,” Pass said in an email to MobiHealthNews. “Whether it is their own physician/weight loss specialist’s office or remotely through the Ro platform, easy access for a stigmatized condition like excess weight is critical. As a pharmacist, and someone who has struggled with weight, hearing from over 2,000 consumers in market research who are overweight or have obesity, I know it can be tough to feel comfortable asking how and where to get help. Increased access to weight loss approaches will enable better outcomes.”
Editor's note: A previous version of this article called Plenity a medication. It is classified by the FDA as a Class II Medical Device. The article has been updated to refer to Plenity as a product instead of a drug.