VistaGen Therapeutics (NASDAQ: VTGN) Featured Research Report
17 A EGIS C APITAL C ORP. Gabapentin (e.g. Gralise) and pregabalin (Lyrica) have been cited as efficacious. Olanzapine (Zyprexa) and quetiapine (Seroquel) are also included as options. Additionally, the beta adrenergic blockers such as propranolol (Inderal) and atenolol (Tenormin) are mentioned as efficacious, in some situations. Finally, agents including bupropion SR (e.g. Wellbutrin), clomipramine (Anafranil), topiramate (e.g. Trokendi), and divalproex were cited as second-line options with limited evidence for efficacy. 6 Only three drugs, all oral antidepressant drugs (ADs), are approved by the U.S Food and Drug Administration (FDA) specifically for treatment of SAD, and no drug is FDA-approved for acute, on-demand treatment of SAD, we believe. There are three antidepressants specifically approved by the FDA for SAD, although none approved for acute, on-demand treatment. We note the generally slow onset of these drugs. While benzos and beta-blockers are often prescribed off-label, they may – benzos in particular – have safety issues regarding dependence, and alcohol-like side effects. In a drug safety communication issued by the FDA on September 23 rd , 2020, the agency announced that the FDA would be requiring a boxed warning update to improve the safe use of the benzodiazepine (benzo) drug class, including noting the potential for abuse, addiction, and other serious risks. The key differentiator, in our view, for PH94B is how fast it works, and that, to the extent we have seen, it does not carry dependency risks, and that its side effect profile is much cleaner than alternatives, meaning it works fast and doesn’t incapacitate the user, making it ideal for administration shortly before anxiety-inducing activities, which could include everything from speaking to one or a few people, to large public gatherings, and everything in-between. 2 Likewise, for PH10, we believe the drug’s differentiated profile, as demonstrated in the successful Phase 2A trial, will lend itself to use – if and when approved. We note that studies have shown that 67% of patients fail their first antidepressant. We think PH10 could see use as a first alternative following an initial failure to an existing commercial antidepressant. The safety profile in particular in compelling, and we think (1) safety/low side effects, (2) efficacy, and (3) rapidity of efficacy, are important considerations in the antidepressant landscape. VistaGen Therapeutics, Inc. October 8, 2020
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