Issue 187
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.
Here’s what’s going on in prescription digital therapeutics and FDA-regulated digital health this past week…
- Thanks to everyone who responded to my two-question survey last week about the fate of Pear Therapeutics. I’ve spent much of the week poring through the many responses. If you missed it last week and want to weigh in before I write about it next week, take the quick survey here.
- Following last week’s round-up of lobbyist dollars in 2022… a few readers also wrote in to help explain why pain management-focused pharmaceutical company Grunenthal lobbied Congress in favor of the Access to Prescription Digital Therapeutics bill last year. (As I wrote last week, I’m not aware of the company’s work in the space.) One reader noted that MSK-focused digital health company Fern Health is a joint venture that includes Grunenthal as one of the backers. (I knew that much but I’d be surprised if Fern was interested in a Medicare benefit category for PDTs.) It turns out, Grunenthal has eyed its own move into prescription digital therapeutics for opioid use disorder. I don’t know the status of that internal project, but it does make me wonder if the company is a likely buyer of Pear’s assets.
- One more Pear-related item: Connecticut’s state legislature is considering a bill that would set up a three-month, 1,000-patient pilot of a prescription digital therapeutic for opioid use disorder by no later than January 24, 2024. (I’m guessing this was Pear’s lobbyists at work.)
- Probably nothing: Akili made an odd tweak to its marketing language on its websites this week. It no longer refers to Endeavor Rx as a “prescription-only” medical device. It’s now described as “only available through a licensed health care provider” instead. The company removed the word “prescription” or “prescribed” in a couple of places from its product page. Is this distancing from Pear and the PDT category? Signaling a move away from the Rx channel? Just testing out new marketing copy? Whatever it is — interesting timing.
- The FDA granted a second 510(k) clearance to Alio’s remote patient monitoring patch, hub, and companion software for kidney patients. The peel-and-stick patch can now monitor skin temperature, auscultation, heart rate, hematocrit, hemoglobin, and potassium. Those last three are the new capabilities. More here.
- Better Therapeutics announced plans to lay off 35 percent of its workforce. Better is a cardiometabolic-focused prescription digital therapeutics company that — like Pear and Akili — went public via a SPAC in 2021. (Akili’s SPAC merger occurred in 2022.) Better’s CEO Frank Karbe wrote: “I announced earlier we are taking several actions to ensure the long-term success of our company. Sadly, these actions included a reduction in force impacting approximately 35 percent of our colleagues. We are also implementing other cost savings measures to further extend our financial runway so we can reach critical milestones over the next few months, including potential FDA marketing authorization and subsequent commercial launch of BT-001 in Type 2 Diabetes.”
- Cognito Therapeutics raised a $73 million Series B for its wearable-based neuromodulation treatment for Alzheimer’s.
- OK, one more… Mahana Therapeutics is hiring a biz dev person in Texas. The job posting makes clear that the company’s go-to-market strategy is following the original prescription digital therapeutic sales playbook of doc detailing: “As a member of Mahana’s growing business development team, you will be the first Regional Account Manager to market and sell Mahana IBS in the Texas Region. We are looking for a driven sales professional who is motivated, results-oriented, a self-starter, and experienced in developing local area markets within the Gastroenterology (GI) specialty. The ideal candidate will have passion, be comfortable with ambiguity and change, and have a proven ability to succeed in driving revenue with first-in-class/category new pharmaceutical or medical device product launches within GI, Primary Care and group practice settings.”
Did a friend forward this to you? You, too, can win friends and influence people via newsletter forwards by clicking right here. Become the newsletter-forwarder we both know you were meant to be. Act fast! This offer won’t last forever (I am not immortal).
FDA’s pandemic waiver for psychiatric digital health devices will end on November 7, 2023.
If you remember back in December 2021, the FDA issued a draft guidance on how it planned to transition things back to normal after the COVID-19 public health emergency was officially over. The draft suggested a 180-day transition period for companies, including those that have marketed digital health devices targeting certain psychiatric conditions without first seeking FDA clearances during the pandemic.
At the time Pear Therapeutics argued the FDA should make it a shorter transition period: 90 days should be plenty. Most other companies that were marketing non-FDA cleared devices asked the FDA for more time — maybe a full year for the transition.
Well, this week the FDA issued the final guidance and it’s basically what the draft version laid out.
The transition period is a 180-day, three-phase transition, which will begin the day the Biden Administration declared the public health emergency will be considered over — May 11, 2023. So, on November 7, 2023, the enforcement discretion for psychiatric digital health devices will be lifted. By that date, the agency will expect device manufacturers to have secured market authorization or pull their therapies from the market. (I won’t get into all the details — best read the guidance for those.)
I asked Software as Medical Device expert and FDA lawyer Jason Brooke of Brooke & Associates if the FDA’s 180-day transition period was enough time for a company to secure FDA clearance. “That depends on whether they’ve been preparing for the transition or not. For some, it will be enough time. For others, probably not,” Brooke wrote. I wondered if the FDA might give companies in this situation special treatment since it was an unusual circumstance.
Here’s Brooke again:
“I don’t see the FDA giving any special treatment for this category of devices but I could see individual companies getting special treatment (especially if they have good lawyers and/or a government affairs team).”
“What will be interesting is whether the FDA will allow companies to rely on real-world data as evidence to support the regulatory submission. To date, the FDA has postured that they are open to the use of RWE but often the Agency is unsatisfied by what they see. Here, however, there should be plenty of RWD to support the submissions. Whether the FDA will be more lenient is to be determined.”
Finally, one thing that was bothering me was what happens if a company decides that they don’t want to submit to the FDA and they revert their marketing claims to what they were prior to the waiver. Big Health is a good example here since they didn’t launch new products, they just added new treatment claims to their existing ones (see the list below for more details). So, I asked Brooke if a company in that position was able to simply revert back to the old language.
“This is an interesting question. Traditionally, the company would need to be concerned about what’s called ‘priming the market’. That occurs when, typically in a premarket context, the company advertises functionality and/or uses that are not included in the market authorization. In such a situation, the FDA could argue that the company primed the market and, even though they are no longer advertising that particular aspect of the intended use, everyone understands that the previously advertised intended use is still implied. Here, the FDA has authorized people to make claims under the COVID enforcement policy. I suspect that it would be difficult (or at least inequitable) to make the ‘priming the market’ argument. Hence, the approach you suggested does seem like a reasonable path forward.”
Here are the digital health companies that have marketed digital health interventions under the psychiatric waiver (there are other waivers too) that E&O has been tracking (which ones am I missing?) Not all of these were full commercial launches:
- Akili Interactive Lab soft-launched Endeavor but then managed to secure full market authorization for EndeavorRx from the FDA less than two months later (Issue 057)
- Pear Therapeutics soft-launched its schizophrenia prescription digital therapeutic Pear-004 in May 2020 (Issue 050) but any news or updates of this one fizzled out quickly.
- Big Health added a claim to its website that read “Our digital therapeutics are safe and effective non-drug alternatives for mental health.*” and the asterisk further explains that because of the FDA enforcement discretion policy above, for adults “diagnosed with Insomnia Disorder or Generalized Anxiety Disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for Insomnia Disorder or Generalized Anxiety Disorder, respectively.”
- In June 2020 Quit Genius announced that it was expanding beyond its tobacco cessation program. Thanks to the FDA enforcement policy the company said it would “now offer integrated support for alcohol and opioid addictions to help support patients during the pandemic and beyond.”
- In July 2020, thanks to the FDA enforcement policy, Orexo announced an accelerated timetable for two of its long-planned prescription digital therapeutics, which it developed with GAIA: vorvida and deprexis.
- In February 2021, Blue Note Therapeutics very quietly set up a patient-facing brand site for its flagship prescription digital therapeutic, attune. “Attune is available to patients today, but only by prescription from your doctor. Due to COVID-19, the FDA recognizes that cancer patients are struggling now more than ever. Their recent guidance enables the immediate release of attune, while it is also being studied in clinical trials.” It also likely launched a similar site for another pre-FDA prescription digital therapeutic for people with cancer called cerena around the same time, but I only noticed it in June 2021. Cerena is a “digital therapeutic program to aid the physical health of people with cancer.” The program’s modules appear to focus on bone health, kidney health, food poisoning, sun exposure, and more.
- In July 2021 Happify Health sort of soft-launched its prescription digital therapeutic, Ensemble, prior to getting FDA clearance too. Ensemble is a prescription-only digital therapeutic for people with generalized anxiety disorder (GAD) or major depressive disorder (MDD). Happify launched a clinical trial with a design that would have been trickier to pull off without the enforcement discretion policy.
- In October 2021 Limbix soft-launched its SparkRx prescription digital therapeutic pre-FDA clearance thanks to the policy too: “SparkRx is rooted in cognitive behavioral therapy, a therapeutic modality proven to assist with the symptoms of depression and other mental health disorders. SparkRx is an adjunct treatment for teens and young adults aged 13-22 who are experiencing symptoms of depression… SparkRx is accessible via a health care provider and available at no cost to patients for a limited time.”
- Just this week Arcade Therapeutics, formerly known as Wise Therapeutics, announced plans to make its digital therapeutic for Social Anxiety Disorder, named StarStarter Rx, available via the waiver during Q2 o this year via select payer and provider partners. It also plans to submit the device to the FDA. (More on this in the Trials round-up below.)
FDA issues voluntary recall for Withings ScanWatch over ECG doctor review software bug
Withings announced that it had issued a voluntary recall for its ScanWatch smartwatch, which offers both FDA-cleared ECG and pulse ox capabilities. A software bug enabled users to use the ECG feature without an initial reading reviewed by a physician. Withings’ FDA clearance for the device requires a physician to remotely review the first ECG to unlock it for first-time users, which was the case for AliveCor users in past years too.
Apple’s FDA De Novo clearances in 2018 were notable for many reasons, but what made that device novel was that it did not require this initial physician review to unlock the ECG feature. That led to Apple calling it the first direct-to-consumer ECG. In any case, most ECG offerings on consumer wearables no longer have this unlock step. Even AliveCor used Apple’s clearance as a predicate to remove that step from its offering. Fitbit and Samsung did the same. I wonder why Withings didn’t?
Withings told me that this software issue was short-lived and it only affected 1,526 devices. The problem could be corrected with an app update, so the FDA notice is not a physical recall. As part of the recall filing with the FDA, however, Withings had to disclose how many ScanWatch devices are in circulation in the US market: 38,886.
Initially, these watches retailed for just under $500, but the device has dropped to less than half that in some stores. Just to keep it simple: If we assumed all of the devices in the market sold at the original price, that means the ScanWatch generated about $19.4 million in sales to date.
Trials from Arcade (topline results), Apple (cardiac rehab), Dreem (sleep and dementia), and Pear (pilot with Johns Hopkins)
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. Just a handful of studies this week…
Topline results: Arcade Therapeutics (fka Wise Therapeutics) says anxiety digital therapeutic pilot study met primary endpoint
Arcade’s StarStarter Rx uses a cognitive training technique called Attention Bias Modification (ABM) packaged into a mobile game. The study focused on adults with Social Anxiety Disorder (SAD) and, according to the company, it:
“Reduced social anxiety symptoms in more than 90% of patient participants 22-65 with Social Anxiety Disorder, averaging a 33% decrease, a magnitude that was statistically significantly greater than that of the gold-standard placebo control… 68% of patients showed clinically meaningful reductions in their anxiety severity level, with 38% showing reductions to sub-clinical cutoffs.”
Apple, Johns Hopkins University, and AHA to start cardiac rehab study next month, tweak endpoints
The Apple-powered Corrie platform that researchers from Johns Hopkins have developed with the Big Tech company is set to undergo a new trial that is set to begin in April. In this RCT:
“The researchers are investigating whether a multi-component virtual cardiac rehabilitation program in addition to usual care will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with atherosclerotic cardiovascular disease, as compared to usual care.”
The study went through a few tweaks this past week. The researchers removed angina pectoris as a qualifying medical condition for heart patients in the study but added valve heart disease to replace it. The researchers also upped the number of anticipated participants from the round number of 300 to a rather precise 504. Finally, the biggest tweak was to the timeframe for each of the primary and secondary outcomes measures. They were each previously measured over 12 weeks but are now on a 16-week timeframe.
Now recruiting: Dreem, University of Miami, and Shipley Foundation’s treating Alzheimer’s with sleep and exercise study
This is an interesting study that signals sleep-focused wearable device company Dreem is planning to send its device to the FDA. The study is on Dreem’s insomnia-focused cognitive behavioral therapy program and other digital sleep aids powered by Dreem’s headband device. More:
“Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic Cognitive Behavioral Therapy – Insomnia (CBT-I) intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).”
Delayed: Johns Hopkins’ pilot of Pear’s reSET-O for acute settings
This study is still recruiting but JHU updated it this week to show that the study’s primary completion isn’t likely until March 2024 — a year later than its original estimate. More:
“This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.”
Links to E&O’s reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 200 past issues of E&O newsletters here.
