– Company in progresstalks with a Major university research center for design and execution of a proof-of-concept study evaluating ADAIR for the treatment of cognitive impairment associated to COVID-19[female[feminine
PHILADELPHIA, PA, Feb. 28, 2022 (GLOBE NEWSWIRE) — Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs designed to deter abuse in the treatment of central nervous system (CNS) disorders. CNS), today announced that the United States Patent and Trademark Office (USPTO) has issued Patent No. 11,253,490 covering the use of its proprietary investigational formulation of dextroamphetamine, ADAIR, for the treatment of cognitive impairment (sometimes called “COVID brain fog”) associated with COVID-19.
The new US patent covers a method of using ADAIR to treat or relieve symptoms of cognitive impairment in patients who have had a COVID-19 infection, with a basic patent term extending to 2041.
David Baker, CEO of Vallon, said: “The medical community continues to gather data and learn more about COVID-19 and how it manifests in patients. New research suggests there may be long-term neurological consequences in many patients who survive COVID infections, including cognitive impairment and problems with attention. This symptom, sometimes referred to as “COVID brain fog”, can have a significant impact on daily functioning and quality of life for patients and survivors of COVID-19. »
Timothy Whitaker, MD, Vallon’s Chief Medical Officer added, “In light of increasing reports of patients with cognitive impairment associated with COVID-19, and based on data demonstrating the ability of dextroamphetamine to improve cognitive measures in ADHD patients, we believe that ADAIR has the potential to treat/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 concentrating in studies and/or work; showing reluctance or difficulty learning new skills; finding daunting multitasking jobs; confusion; Short-term memory loss; inability to pay attention to a particular thing for a long time; slowness in performing usual tasks; difficulty remembering a conversation or finding the right word to form a sentence; forgotten with picture or list of words; and fatigue, mild depression or anxiety. A recent study of 740 people (with an average age of 49) with no history of memory problems showed that patients treated for COVID-19 still had high rates of these symptoms on average more than 7 months after diagnosis.1. The results of another recently published study found that difficulties with attention, multitasking and speed of processing were common in hospitalized patients recovering from COVID-19 and among the patients in the study, 81% had a some degree of cognitive impairment2.
Based on ADAIR’s potential ability to improve cognitive measures, Vallon is in discussions with a leading academic research center regarding the design and execution of a proof-of-concept study to evaluate ADAIR in patient recovery. COVID-19 who suffer from cognitive or “brain” disorders. foggy symptoms.
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a new, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that may produce a more significant “high.” Dextroamphetamine has been in clinical use for over 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 United States Food and Drug Administration (“FDA”).
About Vallon Pharmaceuticals, Inc.
Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, Pennsylvania. The Company is focused on developing new drugs to help patients with CNS disorders. The Company’s lead investigational product candidate, ADAIR, is a novel immediate-release amphetamine abuse deterrent formulation being developed for the treatment of ADHD and narcolepsy.
For more information about the company, visit www.vallon-pharma.com or connect with us on LinkedIn or Twitter.
References and links to web sites have been provided for convenience, and information contained on such web sites does not form a part of or incorporated by reference into this press release. Vallon is not responsible for the content of third party websites.
This press release contains “forward-looking statements” based on Vallon’s current expectations and subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation, Vallon’s ability to execute its plan. revenues, to continue its growth and to finance its ongoing commercial activities as planned, Vallon’s ability to develop and commercialize its product candidates, Vallon’s expectations regarding the results of clinical trials and studies, the expectations de Vallon with respect to the significant advantages it believes its anti-abuse drug formulation has over similar drugs in the market and the growing need for deterrent drug formulations, Vallon’s ability to use the regulatory pathway 505(b)(2), Vallon’s ability to obtain FDA approval for ADAIR and its other product candidates, ADAIR’s ability to treat disorders cognitive impairment associated with COVID-19, Vallon’s ability to design and execute a proof-of-concept study to evaluate ADAIR in the recovery of COVID-19 patients who exhibit cognitive impairment or “brain fog” symptoms, and Vallon’s expectations regarding its cash trail. Forward-looking statements can be identified by the use of words such as “anticipate”, “believe”, “intend”, “could”, “estimate”, “expect”, “intend”, ” seek”, “may”, “could”, “plan”, “potential”, “predict”, “project”, “target”, “aim”, “should”, “shall”, “would” or the negative of these words or other similar expressions In addition, certain forward-looking statements are based on assumptions about future events that may not prove to be accurate. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Vallon’s quarterly and annual reports filed with The forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to update this information, except as required by applicable law.
JTC Team, LLC
1 JAMA Network Open. 2021;4(10):e2130645. doi:10.1001/jamanetworkopen.2021.30645, Assessment of cognitive function in patients after COVID-19 infection, Jacqueline H. Becker, PhD; Jenny J. Lin, MD, MPH; Molly Doernberg, MPH; et al
2 Neuropsychopharmacology, Frequency and profile of objective cognitive deficits in hospitalized patients recovering from COVID-19Davis et al., 2020 medRxIV, Jaywant et al., 2021