Vallon Pharmaceuticals Announces Issuance of US Patent Covering ADAIR for the Treatment of Cognitive Impairment Associated With COVID-19

Vallon Pharmaceuticals, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued patent No. 11,253,490 covering the use of its proprietary investigational abuse-deterrent formulation of dextroamphetamine, ADAIR, for the treatment of cognitive impairment (sometimes referred to as “COVID brain fog”) associated with COVID-19.

The new US patent covers a method of use for ADAIR for treating or alleviating symptoms of cognitive impairment in patients who have had a COVID-19 infection, with a base patent term extending until 2041.

David Baker, Chief Executive Officer of Vallon, said “The medical community continues to gather data and learn about COVID-19 and the ways in which it manifests in patients. New research suggests that there may be long-term neurologic consequences in many patients who survive COVID infections, including cognitive impairment and attention issues. This symptom, sometimes referred to as COVID brain fog, can have a significant impact on COVID-19 patients’ and survivors’ daily functioning and quality of life. In light of the growing reports of patients experiencing cognitive impairment associated with COVID-19, and based on the data demonstrating dextroamphetamine’s ability to improve cognitive measures in patients with ADHD, we believe ADAIR has the potential to address/improve a number of these troubling symptoms/cognitive measures. We look forward to exploring this further.”

COVID brain fog refers to cognitive impairment experienced by patients who have recovered or are recovering from COVID-19. Symptoms of cognitive impairment include problems in concentration in studies and/or work; exhibiting reluctance or difficulty in acquiring new skills; finding multitasking jobs daunting; confusion; short-term memory loss; inability to give attention to a particular thing for a long time; slowness in completing usual tasks; difficulty in recalling a conversation or finding the right word to form a sentence; forgetfulness with image or list of words; and fatigue, mild depression, or anxiety. A recent study of 740 people (with an average age of 49) with no prior history of memory problems showed that patients treated for COVID-19 still had high rates of these symptoms an average of more than 7 months after diagnosis¹. Results from another recently published study found that difficulties in attention, multitasking, and processing speed were common in hospitalized patients recovering from COVID-19 and of the patients in the study, 81% exhibited some degree of cognitive impairment².

Based on ADAIR’s potential ability to improve cognitive measures, Vallon is in discussions with a major academic research center regarding the design and execution of a proof-of-concept study to evaluate ADAIR in recovering COVID-19 patients who are experiencing cognitive impairment or “brain fog” symptoms.

ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Dextroamphetamine has been used clinically for more than 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall, Dexedrine, and Vyvanse. ADAIR is not approved by the US FDA.

Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The Company is focused on the development of new medications to help patients with CNS disorders. The company’s lead investigational product candidate, ADAIR, is a novel abuse-deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy. For more information, visit www.vallon-pharma.com.