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Indian pharma sees the benefits of US FDA norms on psychedelic drugs going by its potential to treat mental conditions. Even as oncology drug portfolio is seen to indicate the highest demand for medicines, neuro-psychiatry and the psychedelic medicine therapies are showing the much needed efficacy on patients.
To this effect, US FDA has issued a guidance to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions. These cover the entire gamut of psychiatric disorders, substance use disorders. The medicines are psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).
Since 2021, psychedelic drugs are controlled substances in most countries and psychedelic therapy is not legally available outside clinical trials. According to US FDA, in recent years, interest in the therapeutic potential of psychedelic drugs has been increasing. Psychedelic drug development programs are subject to the same regulations and same evidentiary standards for approval as other drug development programmes.
However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of challenges. Psychedelic drugs can cause intense perceptual disturbances and alterations in consciousness that can last for several hours. Some drug development programs incorporate a psychological or behavioral intervention. Investigators hypothesize that psychedelic drugs have both rapid-onset and long-term benefits after only one or a few doses. These and other unusual characteristics should be considered when designing clinical studies so that the results of those studies can be interpretable.
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.
It may be reasonable for clinical studies with certain psychedelic drugs to be initiated under an IND in the absence of the typical animal toxicology testing when extensive human exposure and information are available from previously conducted clinical studies 116 and no serious safety concerns were identified.
An 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.
Although current psychedelic drug development programmes are exploring single-dose or intermittent-dose treatment paradigms, most of the conditions being studied to date in these programs are chronic.
Sponsors should determine the most appropriate dosing paradigm for each animal species in the repeat-dose toxicity studies to support their intended clinical studies. The number and types of nonclinical studies to support approval of a marketing application will largely depend on treatment paradigm.
Experts from the National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, who have conducted clinical studies of many of these drugs, note that stringent regulations are critical going by the drug interactions and could impact the heart and other sensory organs.
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