electroCore seeks FDA clearance for Quell in chemotherapy neuropathy
The application draws on 168 participants, including a preliminary randomized trial using a significance threshold of 0.2.
Adrian Kessler
A potential expansion into cancer supportive care advanced as electroCore, Inc. NASDAQECOR said on Wednesday it submitted a notification seeking FDA clearance for Quell to treat chronic chemotherapy-induced peripheral neuropathy. The submission draws on two studies involving 168 participants.
The company says the 510(k) review will assess substantial equivalence to a legally marketed predicate device. The application itself was not reviewed; the Oct. 28 release does not identify the predicate or give an FDA decision date.
electroCore is a small New Jersey medical-device company selling non-invasive neurostimulation products for chronic pain.
Shares closed at US$7.76 on Nasdaq at 4 p.m. EDT on Oct. 27 NASDAQECOR, before the announcement. That price predates the submission announcement.
Under the FDA's submission process, an acknowledgement of receipt is not marketing clearance. The distinction separates a filing milestone from permission to market a device for the requested use.
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Evidence Comes From A Preliminary Trial
The supporting program includes a randomized trial with 142 participants assigned to active or sham treatment, alongside an open-label study with 26 participants. Quell is a wearable platform delivering non-invasive neurostimulation outside the clinic, but it is not cleared for chemotherapy-induced peripheral neuropathy.
In the randomized trial, the active group improved 11.6 per cent on the EORTC-CIPN20 neuropathy symptom questionnaire, compared with 8.7 per cent for sham. The between-group difference met a pre-specified statistical significance threshold of 0.2, selected because the study evaluated preliminary efficacy.
The release does not provide the exact p value or a confidence interval for that difference. Its description of a proof-of-concept study limits what the result establishes ahead of FDA review.
Neuropathic pain scores fell approximately 40 per cent with active treatment. The release compares that with approximately 24 to 33 per cent in the sham group, without specifying one overall between-group estimate.
A separate analysis of participants with moderate to severe baseline pain found reductions of approximately 50 per cent with active treatment versus 30 per cent with sham. That analysis was not pre-specified, so it remains exploratory.
In the open-label study, 22 participants completed six weeks of treatment and recorded a 13 per cent improvement on the questionnaire. Across the clinical program, the company described Quell-related adverse events as generally infrequent, mild and self-limiting.
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“Following our interactions with the FDA, we have determined to pursue the 510(k) pathway for this indication,” electroCore chief medical officer Peter S. Staats said in the release.
The company describes discussions about the regulatory pathway, without reporting FDA endorsement of the trial design. The proposed indication addresses symptoms caused by cancer treatment rather than treatment of the cancer itself.
Device Peers Treat Diabetic Neuropathy
Boston Scientific Corporation NYSEBSX announced FDA approval on Oct. 11, 2023 for its WaveWriter Alpha spinal cord stimulation systems in painful diabetic peripheral neuropathy. Abbott Laboratories NYSEABT announced approval for its Proclaim XR system on Jan. 26, 2023, with that indication limited to tonic stimulation.
Those approvals concern diabetic neuropathy, a different indication from electroCore's request. The iShares U.S. Medical Devices ETF NYSEARCAIHI was quoted at US$54.53 as of 8 p.m. EDT on Oct. 27, providing a dated sector reference.
electroCore's Aug. 6 financial release reported second-quarter revenue of US$9.5 million, including US$1.3 million from Quell. Its net loss for that quarter was US$3.1 million.
The next regulatory milestone is FDA's determination of whether Quell is substantially equivalent for the proposed use. The Oct. 28 announcement gives no decision date and warns that the agency may request additional information.
