SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 /PRNewswire/ — VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical aggregation developing new bearing medicines for anxiety, abasement and added axial afraid arrangement (CNS) disorders, today arise new in vitro electrophysiology abstracts demonstrating that the apparatus of activity of PH94B, the intranasal neuroactive steroid the Aggregation is advancing for Phase 3 development as a abeyant astute rapid-onset analysis of all-overs in adults with amusing all-overs disorder, does not absorb absolute activation of GABA-A receptors, in audible adverse to the apparatus of activity of benzodiazepines (“benzos”), which act as absolute absolute modulators of GABA-A receptors.
“We are absolute admiring with the after-effects of these studies that advance PH94B’s apparatus of activity may not accept benzodiazepine-like ancillary effects, such as balance and cerebral impairment, or corruption liability,” declared Shawn K. Singh, Chief Executive Officer of VistaGen. “While benzodiazepines accommodate abatement for abounding Americans disturbing with anxiety, their acutely chancy assurance contour does not accommodate itself to continued appellation use. The apparatus of activity contributes to the assurance profile. As we accept apparent in Phase 2 analytic studies, while PH94B is able to aftermath rapid-onset benzo-like, anti-anxiety effects, this abstraction demonstrates that PH94B does not accept a benzo-like apparatus of action. As we access Phase 3 development of PH94B, abnormally accustomed the FDA’s contempo accessible advertisement about assurance apropos associated with benzo use, these new abstracts accomplish us alike added aflame about PH94B’s abeyant to change lives after the chancy ancillary furnishings and assurance apropos of benzos.”
Recently, the U.S. Food and Biologic Administration (FDA) arise a Biologic Assurance Communication (DSC) account the risks associated with use of benzodiazepines, a chic of drugs frequently assigned for analysis of all-overs disorders and added conditions. According to the FDA communication, 92 actor benzodiazepine prescriptions were abounding in 2019. The FDA’s DSC abundant assurance apropos apropos the austere risks of abuse, addiction, concrete dependence, and abandonment reactions affiliated to abiding use of benzodiazepines, and the FDA arise that it is astute an adapted Boxed Warning, the FDA’s best arresting blazon of assurance warning, for all benzodiazepine medications.
“We anticipation it was important to conduct a abstraction to advice differentiate the apparatus of activity of PH94B from that of benzodiazepines, therefore, we apprenticed with EuroFins Discovery to actuate whether PH94B has absolute modulatory furnishings on GABA receptors application in vitro application catch electrophysiology,” acclaimed Mark A. Smith, M.D., Ph.D., Chief Medical Officer of VistaGen. “Benzodiazepines such as alprazolam and diazepam arbitrate their anti-anxiety furnishings by acting as absolute modulators at GABA receptors to accomplish them added acknowledging to GABA and thereby access inhibitory neuronal activity in the brain. PH94B had no agonist or adversary furnishings on GABA receptors. While PH94B may adapt autogenous GABA circuits in the brain, it does not arise to anon bind to or attune GABA receptors at concentrations <10mM, which differentiates its apparatus of activity from benzodiazepines.”
These studies are cogent because they announce that PH94B has no accordant benzodiazepine-like activity. With boundless anxiety-provoking stressors accompanying to the COVID-19 pandemic, civilian unrest, acclamation results, the economy, and ambit acquirements during 2020, the cardinal of individuals adverse all-overs disorders is ascent and a safer analysis another to benzodiazepines is imperative. PH94B may accept the abeyant to displace benzodiazepines and become the safer another in the biologic analysis archetype for all-overs disorders.
About PH94BPH94B is an avant-garde odorless constructed neuroactive steroid nasal aerosol with ameliorative abeyant in a advanced ambit of brainy bloom disorders involving all-overs or phobia. Self-administered in microgram-level doses, PH94B produces accelerated access (within about 15 minutes) anti-anxiety furnishings and does not crave systemic uptake and administration to accomplish these effects.
VistaGen is currently advancing PH94B for cardinal Phase 3 development as a abeyant astute analysis of all-overs in adults with Amusing All-overs Ataxia (SAD). The FDA has accepted Fast Track appellation for development of PH94B for this indication, believed to be the aboriginal such appellation by the FDA for a biologic applicant for SAD.
With its rapid-onset pharmacology, abridgement of systemic acknowledgment and sedation, and its accomplished assurance contour in all studies to date, we accept PH94B has abeyant to accommodate a safe another to benzodiazepines and added pharmacological alternatives in the biologic analysis archetype for all-overs disorders. View added accomplishments advice on SAD and a video on PH94B’s apparatus of action.
About VistaGenVistaGen Therapeutics is a clinical-stage biopharmaceutical aggregation developing and commercializing differentiated new bearing medicines that go above the accepted accepted of affliction for anxiety, abasement and added CNS disorders. Each of VistaGen’s three biologic candidates has a differentiated apparatus of action, an aberrant assurance contour in all studies to date, and ameliorative abeyant in assorted CNS markets. For added information, amuse appointment www.vistagen.com and affix with VistaGen on Twitter, LinkedIn and Facebook.
Forward Looking Statements
Various statements in this absolution are “forward-looking statements” apropos VistaGen’s approaching expectations, affairs and prospects, including the abeyant for acknowledged Phase 3 development of PH94B. These advanced statements are neither promises nor guarantees of approaching performance, and are accountable to a array of risks and uncertainties which could account absolute after-effects to alter materially from those advised in these advanced statements, including the risks that: development and approval of PH94B may not be accomplished in any market; the FDA may adjudge that the after-effects of the Company’s PH94B Phase 3 analytic affairs are not acceptable for authoritative approval for astute analysis of all-overs in developed patients with SAD or any added anxiety-related disorder; development of PH94B may not be acknowledged in any indication; success in nonclinical studies or in earlier-stage analytic trials may not be again or empiric in approaching studies which may not abutment added development or be acceptable to accretion authoritative approval to bazaar PH94B; adverse contest may be encountered at any date of development that abnormally appulse added development. Added risks and uncertainties include, but are not bound to, issues accompanying to: adverse healthcare reforms and changes of laws and regulations; accepted industry and bazaar conditions; accomplishment and business risks, which may include, but are not bound to, dearth of or delays in commitment of raw abstracts for accomplish of PH94B; bare and/or abortive accumulation of PH94B to accommodated demand; access of aggressive products; and added abstruse and abrupt hurdles in the development, accomplish and commercialization of PH94B, as able-bodied as those risks added absolutely discussed in the area advantaged “Risk Factors” in VistaGen’s best contempo Annual Report on Form 10-K for the year concluded March 31, 2020, as able-bodied as discussions of abeyant risks, uncertainties, and added important factors in either company’s added filings with the Securities and Exchange Commission. In addition, any advanced statements represent the Company’s angle alone as of today and should not be relied aloft as apery its angle as of any consecutive date. The Aggregation absolutely disclaims any obligation to amend any advanced statements.
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SOURCE VistaGen Therapeutics
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