Issue 207
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
Two quick things happening in FDA-regulated and pharma-focused digital health before digging into a few scoops about Big Health, Apple-Natural Cycles, and clinical trials…
- The news you know: Click Therapeutics inked yet another deal with a pharmaceutical company. Typically these announcements include some dollar amounts about the potential revenue the companies expect to generate from the partnership, but this one doesn’t: “Click Therapeutics today announced the execution of a new collaboration agreement with Indivior for the development and commercialization of prescription digital therapeutics to treat substance use disorders, beginning with Opioid Use Disorder (OUD). Through a novel mobile application, CT-102, the collaboration aims to help close major gaps in OUD treatment, such as access to high-quality, personalized psychosocial treatment.”
- Here’s an interesting FDA clearance: Ochsner Health, the health system in Louisiana, just secured a 510(k) for a connected inhaler device, called The Ochsner Connected Inhaler Sensor System. Ochsner used Propeller’s connected inhaler sensor as its predicate device and the summary document for the 510(k) makes clear that the two are more or less the same in terms of functionality. I know Ochsner has been ahead of the curve with remote patient monitoring programs since the advent of digital health, but I’m surprised to see a health system create its own connected devices. Any other examples of this?
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After months of deliberation, Big Health is seeking FDA clearances
After publicly hemming and hawing about whether it would seek FDA clearances for its digital therapeutics, E&O has learned that Big Health has decided to go for it.
During the public health emergency (PHE) Big Health changed its marketing language thanks to an enforcement policy the FDA issued for psychiatric digital health devices. Big Health made specific treatment claims for its digital health programs that would typically require FDA market authorization but didn’t thanks to the policy. As this PHE-era policy comes to an end in November, Big Health needed to decide whether it wanted to continue making specific treatment claims for its product or revert back to its pre-pandemic messaging.
Here’s what the claims look like on the Big Health site:
“During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively. Users are directed to not make any changes to their prescribed medication or other type of medical treatment without seeking professional medical advice.”
Big Health wants to continue to make these outcomes claims because it thinks not doing so may jeopardize its current employer customers or make it more difficult to attract future customers — both future employers and individual users of its products.
Big Health will be able to continue to make claims while it is in the process of seeking FDA clearance. It expects the FDA to make a decision about its 510(k) submissions between June 2024 and December 2024. I’m assuming Big Health filed two separate submissions for versions of Sleepio (insomnia) and Daylight (generalized anxiety disorder).
Big Health has also made clear that it will pursue depression as its next likely indication, but it has plans to tackle other medical conditions beyond depression.
Perhaps related: Big Health recently filed for a trademark of the brand name Meadow.
More on Big Health in next week’s newsletter on Selling to Employers.
FDA clears Natural Cycles app to receive body temperature data from Apple Watch
Natural Cycles hasn’t announced this yet, but the FDA recently granted the company another 510(k) that allows its app to receive temperature data from Apple Watches. The indications for use statement for the Natural Cycles app remains the same:
“Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).”
While NC’s last 510(k) added automatic input from Oura Rings, the latest clearance shows a new option for automatic input: Apple Watches.
- Manual input of two decimal daily basal body temperature (BBT) measurements, or automatic input from the Oura ring or Apple Watch.
- Manual input of information about the user’s menstruation cycle, i.e., start date, number of days.
- Optional manual input of ovulation or pregnancy test results.
As I wrote back in 2021 when Natural Cycles received FDA clearance to add the Oura Ring as an data source:
“Oura offers an API and Natural Cycles made use of that for this clearance. It had no agreements in place with Oura as of the time of its new FDA clearance. The clearance marked the beginning of a process that Natural Cycles hopes to build on. The company is currently conducting validation studies of other wearable devices that have temperature-sensing features. It expects a validation study is all it needs to expand its latest FDA clearance to include more wearables. It doesn’t believe it will need to file a 510(k) for each new off-the-shelf data input option it validates.”
Well, it turns out Natural Cycles needed a new 510(k) to add the Apple Watch as a new off-the-shelf data input option.
Given the timing, I’m curious if this gets a mention at Apple’s event next week…
Trials: MedRhythms, Cognoa, Swing, BehaVR, and GAIA
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues.
Terminated: Study on tech that powers Cognoa’s autism digital therapy
A study led by Cognoa’s founder Dennis Wall was terminated with only one word as an explanation: COVID-19. The study only recruited 20 participants out of the anticipated 80. While this study is focused on Superpower Glass and never mentions Cognoa by name, that is the underlying tech of Cognoa, which the company has an exclusive license to commercialize. More:
“The following study aims to understand the mechanism of action at work in a novel artificial intelligence (AI) tool that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This study will examine 2 versions of software on the Google Glass based wearable intervention system. Participants will receive 1 of 2 versions of the software and use the device at home for 4 weeks. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that both mechanisms under investigation will contribute to social gains in children over the 4 week period of use.”
New: Gaia study on digital therapeutic for psoriasis
In Germany, Gaia is studying a new digital therapeutic focused on psoriasis. More:
“This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis. Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.”
MedRhythms reveals details about its pivotal trial
The details of this study were previously redacted and withheld from the government’s clinical trials database as MedRhythms was seeking FDA market authorization. Now that InTandem is listed with the FDA as a medical device, it released the details of its pivotal trial. More:
“The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.”
Done recruiting: Swing Therapeutics REACT-FM trial
No word yet on whether Swing managed to recruit the 500 participants it had originally anticipated, but the company reports that it is no longer recruiting for its REACT-FM trial. More:
“The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.”
New: BehaVR Phase II trial on opioid use disorder digital therapeutic
Click Therapeutics isn’t the only company developing a digital therapeutic for OUD in the wake of Pear Therapeutics’ bankruptcy earlier this year. Here’s more on BehaVR’s Phase II study on MORE-VR:
“The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. The main question it aims to answer is will people with opioid use disorder who receive the study intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have fewer days in which they use opioids than will people who just receive their usual treatment. Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in addition to their usual treatment, or treatment as usual only. Researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.”
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