Theranica received FDA approval for its smartphone-controlled electroceutical for the acute treatment of migraine.
This is yet another digital therapeutic that received approval on the basis of a placebo-controlled clinical trial (another noteworthy example is Pear Therapeutic's offering, in collaboration with Novartis/Sandoz).
It appears that we are seeing the beginning of a more stringent approach for digital health and therapeutics development, including multi-center, placebo-controlled clinical trials. It will be exciting to see the first head-to-head trial of a digital Tx vs. a classical pharmaceutical, as well as the combination of digital and classical therapy in a trial.
It will be interesting to see how the payors are going to react to this change in the landscape.
The FDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.