Swing’s digital therapy for fibromyalgia gets FDA nod

Swing Therapeutics has joined the ranks of digital therapeutics (DTx) developers with an FDA-approved product, after the regulator greenlit its Stanza app for people with fibromyalgia.

The de novo marketing authorisation is the first for a DTx for fibromyalgia, a common condition causing chronic pain, fatigue, poor sleep, and cognitive dysfunction that, according to Swing, affects more than 10 million people in the US.

Stanza, which is delivered via a smart device, provides a form of cognitive behavioural therapy (CBT), which is generally recommended as a first-line therapy for people with fibromyalgia, with drug therapies using antidepressants like duloxetine and milnacipran typically reserved as a fall-back option, as they can cause side effects.

Swing’s app is based on a form of CBT known as acceptance and commitment therapy (ACT), which according to the company has been shown in multiple randomised controlled trials to be effective in reducing the severity of fibromyalgia symptoms.

Stanza takes the form of a 12-week, self-guided programme that was put to the test in the PROSPER-FM study that revealed that 73% of patients had improvements in fibromyalgia symptom reporting by the end of the programme, measured using the Patient Global Impression of Change (PGIC) scale.

Last month, the digital health company also reported results from a long-term extension of another study – REACT-FM – which looked at as-needed use of the app over a 12-month period from the start of the main programme.

In that case, the proportion of patients reporting improved fibromyalgia using PGIC was consistently above 80% across all follow-up timepoints, while another rating scale (the Revised Fibromyalgia Impact Questionnaire or FIQ-R) showed an average improvement of 25% over the follow-up period.

There were also reductions in the proportion of subjects reporting anxiety and depression, according to Swing.

Stanza has been made available to patients since September 2022 under the FDA’s Digital Health Enforcement Policy for Digital Health Devices, which was first enacted during the pandemic to make it easier for patients to access CBT and other low-risk DTx amid lockdown restrictions.

FDA approval is no guarantee of success in the current DTx market environment – just look at the fortunes of Pear Therapeutics – but Swing is hopeful that the sheer number of people who suffer from fibromyalgia in the US will be in its favour, along with a breakthrough device designation for Stanza it was awarded last year.

The company is also working on a companion app to help patients track their fibromyalgia symptoms on a daily basis, and fine information and advice about the condition. Last year, it also launched an online clinical service – called Swing Care – to focus on holistic treatment for fibromyalgia patients with DTx as a care option.