How the New Once-a-Day Deutetrabenazine Pill Helps Patients

Rakesh Jain, PhD, MS

Deutetrabenazine (Austedo XR; Teva Pharmaceuticals) helps treat people with chorea, which is characterized by involuntary, dance-like movements, and tardive dyskinesia associated with Huntington’s disease (HD). Initially approved in 2017 for chorea associated with HD, it received a label expansion soon after for tardive dyskinesia, as well. Deutetrabenazine was the first of its kind approved by the FDA for these conditions. It works by controlling movements in the arms, legs, face, and other parts of the body, while also helping with other symptoms like muscle stiffness, unusual eye movements, trouble walking, balance issues, and difficulties with speaking or swallowing.

Recently, the FDA approved a new, once-daily pill option for deutetrabenazine, which comes in four new dosages (30, 36, 42, and 48 mg). This new pill option makes it easier for patients to manage their medication since they only have to take it once a day, improving their ability to stick to the treatment plan, which can be hard for people with HD who often struggle with taking multiple pills.

Rakesh Jain, PhD, MS, a professor of psychiatry at Texas Tech University School of Medicine, spoke with The Educated Patient's sister site Neurology Live about how this approval benefits both doctors and patients. He explained the importance of treating chorea and tardive dyskinesia and shared that this medication brings promising safety features. One of the best parts is that patients can take it without worrying about timing or food restrictions, making their daily routine easier.

NeurologyLive: What does this new approval bring to patients with Huntington disease and those with tardive dyskinesia?

Rajesh Jain, MD: As you already know, tardive dyskinesia and Huntington are pretty big challenges, and pill burden is a substantial issue with both of these two populations. The approval of Austedo XR (deutetrabenazine) as one pill, once a day across the therapeutic dose range is, I think, a strikingly big deal for three sets of people. Of course, the most important is patients. With patients and the pill burden, that reduced number of pills a day really improves adherence and compliance. But the other is the family. Both groups have patients that are often taken care of by families and they prefer simplicity and straightforwardness, they kind of worry that if there's more pills, then somehow the patient is sicker. The third constituency that should not be ignored is the health care community. We don't like [administering drugs] multiple times a day, we don't like multiple pills a day. Across the board, this one tablet, once a day across therapeutic dose range is a win-win-win situation.

How does this decision differ from the February 2023 approval of the once-daily extended-release formulation?

The previous one tablet, once a day applied to only a few doses. At that time, we only had 6, 9, and 12 mg as opportunities. Now the portfolio is dramatically bigger. We now have therapeutic dose ranges of 24, 30, 36, 42, and 48 mg. Because of this new approval, we have one tablet, once a day as an opportunity. Besides the psychological impact, once a day, one tablet also is an administration advantage. There are no downsides, and all I can see are significant upside to this new approval by the FDA.

From a safety perspective, are there any notable concerns? Any drug-to-drug interactions clinicians should be aware of?

If you're switching from Austedo to Austedo XR, there is no need to cross taper, down titrate, up-titrate. You go from a dose to dose number. Secondly, pharmacokinetic-wise, the twice-a-day administration of Austedo and the once-a-day administration of Austedo XR are biosimilar. Besides what we already know about the safety drug-drug issues with the drug interaction issues with Austedo, there's nothing new to be added with Austedo XR. There are however, some additional advantages. Perhaps the biggest one is the food effect is no longer part of the label. Before, you had to take Austedo in a certain prescribed way after food, but for Austedo XR, you can give it both ways. You can imagine from a practical perspective how useful Austedo XR becomes to both the neurologist but also to the patient and their family.

Does the timing of when to administer the therapy impact its efficacy/outcomes?

No, the approval of Austedo XR is once-a-day. It doesn’t have to be prescribed specifically in the AM or afternoon or PM. As practicing clinicians, it is our job to fit the medication into the patient's needs. Being able to take Austedo XR anytime of the day is a big deal. The fact that the food effects are no longer a significant barrier further add to my thinking that Austedo XR is becoming a preferred way to treat our patients with either HD chorea or tardive dyskinesia.

Are there any major unmet needs for these patient populations we’re still working to handle?

Huntington disease is a challenge. It's literally a multi-headed monster. There isn't one challenge, we have a whole host of challenges. The mood aspects with HD, that's still a challenge to treat. The other big challenge, of course, is the progression of the illness. We don't really have disease modifying agents, but I also want to remind people that the chorea part of Huntington disease is a major destroyer of quality of life. Choking, falling, trouble speaking, these are huge robbers of the quality of life for these patients with Huntington quite unfortunately. Austedo XR could offer them the service of reducing the chorea form activities, which of course, then in turn, is expected to lead to downstream benefits. While we await the arrival of disease modifying agents, we really ought to celebrate the progress we keep making in the treatment of Huntington chorea. I predict that Austedo XR will become a very important ally of our patient when they're dealing with Huntington chorea.

An original version of this article was published on sister site Neurology Live.