NeuroMetrix Reports that Quell® Wearable Neuromodulation Device has Received FDA De Novo Authorization as First Non-Pharmacological Treatment for Fibromyalgia
May 19 2022 - 9:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today announced U.S. Food and Drug
Administration (FDA) De Novo authorization to market the Quell
neuromodulation device as an aid for reducing the symptoms of
fibromyalgia in adults with high pain sensitivity. The Company
received FDA Breakthrough Designation for the use of Quell to treat
fibromyalgia in July 2021.
Fibromyalgia is a chronic condition characterized by generalized
pain, fatigue, poor sleep, memory and concentration impairments,
mood disorders and other disabling symptoms. These individuals
experience low health-related quality of life and are twice as
likely to be hospitalized as someone without fibromyalgia. The
prevalence of fibromyalgia is estimated to be 2 to 6 percent of the
U.S. adult population (5 to 15 million people). The cause of
fibromyalgia remains unclear, but scientific studies point to
abnormalities in the way the central nervous system processes
normal sensations and pain. Although a number of drugs are used to
treat fibromyalgia only pregabalin, duloxetine and milnacipran have
been approved by the FDA. These drugs are associated with side
effects and generally poor adherence. Prior to Quell, the FDA had
not approved or cleared any medical devices for treatment of
fibromyalgia.
The data submitted by NeuroMetrix in support of the De Novo
request included results from a double-blind, randomized,
sham-controlled trial (NCT03714425). A total of 119 subjects with
fibromyalgia were enrolled and randomized to a standard (active) or
modified (sham) Quell device for 3-months of at-home use. In a
pre-specified subgroup analysis of subjects with high pain
sensitivity (N=60), Patient Global Impression of Change (PGIC) was
1.25 (95% CI [0.25, 2.24]) points higher in the active arm compared
to the sham arm (p=0.015). PGIC was the primary study outcome
measure and represents a subject’s overall belief about the
efficacy of treatment on a 7-point categorical scale. The high pain
sensitivity subgroup was defined based on Quantitative Sensory
Testing and should represent the majority of fibromyalgia patients
in real-world practice.
In the intention-to-treat (ITT) analysis of all randomized
subjects (N=119), multiple secondary outcome measures were
positive. For example, 57% of those on active treatment exhibited a
clinically meaningful improvement in health-related quality-of-life
(Fibromyalgia Impact Questionnaire, FIQR) compared to 34% that
received sham treatment (p=0.014). Subjects in the active treatment
arm reported statistically significant improvements in 19 of the 21
symptoms comprising the FIQR instrument, including pain, sleep,
fatigue, balance and the ability to carry out typical daily
activities. Some of the trial results were published in the Journal
of Pain Research recently.
A total of 9 adverse events were reported during the study and
deemed to be definitely or possibly related to device use (4 in
active arm, 5 in sham arm). All events were minor and self-limited.
The most common occurrence was a rash under the Quell
electrodes.
“There is an unmet need for effective and safe fibromyalgia
treatments. Receiving this De Novo authorization is a key milestone
towards the Company's goal of making Quell available as a
prescription treatment option for people living with fibromyalgia,”
said Shai N. Gozani, M.D., Ph.D., Chief Executive Officer,
NeuroMetrix. "We believe physicians treating patients with
fibromyalgia will be interested in Quell's potential clinical
benefits and safety profile. Our initial commercialization efforts
will focus on rheumatologists and pain medicine physicians. We
anticipate launching in the fourth quarter, with initial
prescriptions processed by an online pharmacy partner before the
end of this year.”
NeuroMetrix was advised by MCRA, LLC in this submission.
Indications
Quell Fibromyalgia is a transcutaneous electrical nerve
stimulation (TENS) device indicated as an aid for reducing the
symptoms of fibromyalgia in adults with high pain sensitivity. The
device may be used during sleep. The device is labeled for use only
with compatible NeuroMetrix electrodes.
LimitationsThe sale, distribution, and use of Quell Fibromyalgia
is restricted to prescription use in accordance with 21 CFR
801.109. Many participants in the clinical study were also taking
medication for fibromyalgia and it was difficult to assess the
effects of the device compared to medication.
The product labeling should be reviewed for a complete list of
contraindications, precautions and warnings.
About Quell Technology
Quell is an advanced, non-invasive, neuromodulation technology
that is covered by 23 U.S. utility patents. It is the only wearable
neuromodulator that is enabled by a proprietary microchip that
provides precise, high-power nerve stimulation in a form factor the
size of a credit card. Quell utilizes position and motion sensing
to automatically adjust stimulation for an optimal user experience
both day and night. The device supports Bluetooth® low energy (BLE)
to communicate with mobile apps for multiple smartphone and
smartwatch platforms.
About NeuroMetrix
NeuroMetrix is an innovation-driven company with a mission to
improve individual and population health through innovative medical
devices and technology solutions for neurological disorders and
pain syndromes. The Company has three commercial products.
DPNCheck® is a diagnostic device that provides rapid, point-of-care
detection of peripheral neuropathies. ADVANCE® is a diagnostic
device that provides automated, in-office nerve conduction studies
for the evaluation of focal neuropathies. Quell® is a wearable
neuromodulation technology indicated for treatment of fibromyalgia
symptoms and chronic lower extremity pain. For more information,
visit www.NeuroMetrix.com.
Source: NeuroMetrix, Inc.Thomas T. HigginsSVP and Chief
Financial Officer781-314-2761neurometrix.ir@neurometrix.com
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