MS News That Caught My Eye Last Week: Nasal Spray Treatment, Anxiety Management, POMS, PoNS
SPMS Patient First to Be Treated With Antibody Given via Nasal Spray
How great is this? As someone who gave himself an injection in his thigh for many years and received IV infusions for many more, an MS antibody treatment sprayed into the nose is wonderful news. This approval only applies to one patient, however. A Phase 1 clinical trial is underway, and a Phase 2 is expected to begin later this year. I hope this nasal spray, which initially was intended to be an oral medication, proves to be safe and effective.
For a first time, an immune-modulating antibody will be given via nasal administration to treat a person with secondary progressive multiple sclerosis (SPMS).
The U.S. Food and Drug Administration (FDA) approved a request to use the antibody — a fully human anti-CD3 monoclonal antibody called foralumab — under an Individual Patient Expanded Access Program, the therapy’s developer, Tiziana Life Sciences, announced in a press release.
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Wise Will Seek FDA Approval for Digital Anxiety Management Therapy
The technical description of this proposed anxiety treatment is a “gamified digital experience” designed for “attention bias modification.” In “people talk,” I think that translates to a digital game designed to divert a person’s attention away from stress triggers. But note that this therapy is being studied to treat people with two other conditions in addition to MS. Unfortunately, its manufacturer only intends to choose one of the three groups for its final product.
Wise Therapeutics intends to seek U.S. Food and Drug Administration (FDA) approval of an anxiety management therapy for multiple sclerosis (MS), following the positive results of a clinical trial.
In addition to conducting a proof-of-concept study in MS, Wise tested its digital technique — called attention bias modification (ABM) treatment — in alcohol use disorder and for perinatal anxiety among pregnant women.
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PoNS Device to Help Adults in Rehab for Walking Problems Gets FDA Approval
Last year, when the PoNS device was being developed, I wrote a column about it. I wondered if someone would be willing to have a mild electrical current applied to the tongue to improve their walking. I’m not sure I would, would you?
The U.S. Food and Drug Administration (FDA) has authorized the use of a medical device called Portable Neuromodulation Stimulator or PoNS as a short-term treatment for walking difficulties in people with multiple sclerosis (MS).
PoNS, developed by Helius Medical Technologies, is a noninvasive medical device that, when placed on the tongue, delivers mild electrical signals to the brain via two major cranial nerves.
The mouthpiece is connected, via a cord, to a controller that is worn around the neck. By sending these electrical impulses, the device is believed to promote neuroplasticity — the brain’s ability to “rewire itself” in response to new experiences.
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In Real World, Tysabri Lessens Disease Activity, Reduces Relapses in Pediatric-onset MS
Pediatric-onset MS (POMS) is a diagnosis applied to patients under 16. It accounts for about 5% of all MS diagnoses. Tysabri isn’t yet approved to treat POMS, but as it and other disease-modifying therapies prove to be safe and effective for these young MS patients, I hope regulators move quickly to do so. Many neurologists believe that the earlier MS can be treated, the more likely it is that its progression can be slowed or stopped.
Off-label treatment with Tysabri (natalizumab) significantly lessens disease activity and reduces the number of relapses per year in patients with pediatric-onset multiple sclerosis (POMS), real-world data from Portugal show.
The treatment also was considered safe in this population, in agreement with earlier studies. These findings support the usefulness of Tysabri for treating MS patients who develop the disease during childhood, the researchers said.
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