Summary: Indian pharma companies are starting to see the benefits of the US FDA’s norms on psychedelic drugs, given their potential to treat mental conditions. The US FDA recently issued guidance to provide general considerations to sponsors developing psychedelic drugs for the treatment of medical conditions. These drugs include psilocybin, LSD, and MDMA, which cover a wide range of psychiatric disorders and substance use disorders.
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US FDA’s Psychedelic Drug Norms Benefit Indian Pharma Companies
Indian pharmaceutical companies are starting to see the benefits of the US FDA’s norms on psychedelic drugs, given their potential to treat mental conditions. The US FDA recently issued guidance to provide general considerations to sponsors developing psychedelic drugs for the treatment of medical conditions. These drugs include psilocybin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA), which cover a wide range of psychiatric disorders and substance use disorders.
Since 2021, psychedelic drugs have been controlled substances in most countries, and psychedelic therapy is not legally available outside clinical trials. However, interest in the therapeutic potential of psychedelic drugs has been increasing. Psychedelic drug development programs are subject to the same regulations and evidentiary standards for approval as other drug development programs. However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of challenges due to their intense perceptual disturbances and alterations in consciousness that can last for several hours.
Sponsors must provide sufficient chemistry, manufacturing, and controls information to ensure proper identification, quality, purity, and strength of the investigational drug substance and drug product. This is true for all phases of clinical trials. Those companies interested in conducting a clinical investigation with a psychedelic drug under an IND (Investigational New Drug Application) must either submit their own information.
The IND must include adequate information about pharmacological and toxicological studies of the drug on the basis of which the sponsor has concluded it is reasonably safe to conduct the proposed clinical investigations. Therefore, psychedelic drugs without a history of adequate clinical exposure should not be tested in humans until safety has been established in nonclinical studies, said the global regulatory authority.
In conclusion, the US FDA’s norms on psychedelic drugs present a significant opportunity for Indian pharmaceutical companies. More to come.[Source: PharmaBiz]
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