Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.
The EUA indication covers adults who are experiencing exacerbation of asthma-related dyspnea and reduced airfow, for whom drug therapies either aren’t tolerated or provide insufficient relief.
Gammacore is applied at to either side of the neck and delivers mild electrical impulses to the vagus nerve through the skin, stimulating the nerve receptors to reduce pain or distress. Patients can administer the treatment themselves, reducing reliance on medications with their potential side effects.
The system is currently FDA-cleared for adjunctive use to prevent cluster headaches in adults, as well as for the acute treatment of pain associated with episodic cluster headaches and migraines. In March, the Basking Ridge, N.J.-based company received a further expansion of its 510(k) clearance to include the prevention of migraine headaches in adult patients.
In the European Union, Gammacore is CE marked for both acute and preventive treatment of primary headaches, including cluster and migraine, as well as bronchoconstriction and medication overuse headache in adults.
Early clinical evidence
The FDA based the EUA on preliminary data from two ongoing, prospective, multicenter, open-label, investigator-initiated studies looking at Gammacore’s impact on COVID-19-related breathing problems. Early results from the SAVIOR 1 trial in Valencia, Spain, showed a 73% mean improvement in forced expiratory volume (FEV) after 90 minutes of acute percutaneous VNS therapy. The mean visual analog scale (VAS) dyspnea score – the patient’s subjective feeling of how easily they can breathe – dropped from 8 at baseline, to 1.
In the SAVIOR 2 trial, conducted in Pittsburgh, 93% of patients reported improvement in the VAS dyspnea score and 86% had increased FEV after 90 minutes of NVS treatment.
“Needless to say, we are very pleased to have received the EUA, and we intend to work vigorously to make this novel therapy available to physicians treating known or suspected COVID-19 patients who are experiencing exacerbation of asthma-related breathing difficulty,” said Dan Goldberger, Electrocore’s CEO.
The company said it will provide updates on the pricing and distribution of Gammacore CV under the EUA in the weeks ahead.
Potential new revenue channel
Ryan Zimmerman, an analyst with BTIG, said the EUA could boost Electrocore’s sales by expanding its focus beyond neurologists and headache doctors to respiratory specialists, potentially keeping patients out of the hospital.
“The EUA provides ECOR with a source of major upside and there is some evidence that VNS can be used to block airway reactivity and mitigate cytokine storm, but we still feel it is too early to gauge the true potential of Gammacore for treating patients with COVID-19 until more exhaustive studies have occurred,” he wrote in a Monday note.
Zimmerman said management indicated in May that talking with additional sites in the U.S. about initiating trials of Gammacore for COVID-19-related acute respiratory distress syndrome, but predicted that wider adoption may hinge on positive results from the current studies. “That said, mgmt’s goal would be to establish a pivotal study in these indications and ultimately seek a 510(k) clearance which could potentially add a meaningful new channel of opportunity over time,” he wrote.
J.P. Errico, co-founder and co-inventor of Gammacore and an Electrocore board member, echoed that strategy, calling the EUA “an encouraging first step” toward building evidence to support the expansion of VNS in the area of restrictive airway disease.
BGIT is maintaining its neutral rating for the company.
Electrocore saw solid growth in 2019, with net sales nearing $2.4 million, up from $993,000 the prior year. Nevertheless, the company suspended its 2020 guidance due to uncertainties around the COVID-19 pandemic. Management previously had predicted full-year revenue in the $7 million to $9 million range.
To increase the reliability of its revenue sources, the company has reduced its efforts to reach patients through commercial channels, focusing instead on federal supply schedule entities – comprising the Veterans Administration, Department of Defense and Indian Health Services – as well as the U.K.’s National Health Service.