Gabapentin

• The patent, once granted, will not expire until at least 2034 and will become part of Vistagen’s global patent portfolio on therapeutic uses and manufacturing techniques for AV-101.
• In the study, AV-101 prodrug was systematically administered in four rat models of pain to examine its analgesic and behavioral profile.
• The preclinical study was conducted by Tony L. Yaksh, PhD, Professor of Anesthesiology and Pharmacology at the University of California, San Diego.
• Vistagen plans to seek potential strategic collaborations to further advance the clinical development and commercialization of AV-101.

• The global gabapentin market size is expected to reach USD 3.07 billion by 2030, expanding at a CAGR of 5.35% from 2023 to 2030.
• The other key growth driver is the rising geriatric population which is more to epilepsy and conditions such as neuropathic pain.
• Moreover, developed regions such as North America and Europe are further making policy changes to reduce the burden on the healthcare system by promoting the use of generics such as gabapentin.
• North America is expected to dominate the market over the forecast period, due to a developed healthcare system that facilitates the adoption of drugs such as gabapentin.

• Past public ire over high drug prices has recently taken a back seat to a more insidious problem – no drugs at any price.
• Patients and their providers increasingly face limited or nonexistent supplies of drugs, many of which treat essential conditions such as cancer, heart disease and bacterial infections.
• The American Society of Health System Pharmacists now lists over 300 active shortages, primarily of decades-old generic drugs no longer protected by patents.

A generic problem

• The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate.
• Perhaps the clearest indication of this is the fact that prices of brand drugs in the U.S. are among the highest in the developed world, while generic drug prices are among the lowest.
• But once the patent expires, the drug becomes generic and any company is allowed to manufacture it.

Outsourced production creates more supply risks

• One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.
• While overseas manufacturers often enjoy significant cost advantages over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply.
• The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.
• To ensure domestic supplies, the Indian government restricted the export of medications, disrupting the global supply chain.

Low profits hurt quality

• Manufacturing drugs to consistently high quality standards requires constant testing and evaluation.
• A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high.
• That’s often not the case for generic drug manufacturers, and this can result in shortages.
• Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.

Repatriating the drug supply

• It is hard to quantify the impact of drug shortages on population health.
• However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages led to increased medication errors, delayed administration of lifesaving therapies, inferior outcomes and patient deaths.
• Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.

• The final clinical study report is anticipated to be received by the Company in the first half of 2023.
• The potential benefits of GTX-101 could include faster onset of action and a longer duration of pain relief as compared to the lidocaine patch.
• The study enrolled 48 healthy adult subjects (24 males/24 females, mean age = 36 years), in 12 subjects per cohort.
• Following GTX-101 topical application: headache (3%) and numbness (3%) at the sprayed area, and
  In conclusion, this Single Dose PK study was conducted successfully, and it achieved all its primary outcome measures.