There is no unmet need: CDSCO Panel rejects J&J proposal to Import and manufacture Paliperidone Palmitate
New Delhi: Citing that there is no unmet need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected Johnson and Johnson's proposal to import and manufacture the anti-psychotic drug Paliperidone Palmitate Prolonged Release Suspension for Intramuscular Injection 700mg & 1000mg for the treatment of schizophrenia.
In addition, the committee recommended that the firm should provide data on global and ethnic Indian (or Indian origin) patients on the comparative efficacy of PP6M vs PP3M and PP6M vs PP1M. Furthermore, the expert panel also directed the firm to provide the names of the countries where 6 month injection (PP6M) has been approved without approval of 3 month injection (PP3M).
This came in line with the firm proposal presented by pharma major Johnson and Johnson for the import and marketing of Paliperidone Palmitate Prolonged Release Suspension for Intramuscular Injection 700mg & 1000mg (6 month injection, (PP6M)) for the treatment of schizophrenia in adult patients who have been adequately treated with the 1-month Paliperidone palmitate injectable product for at least 4 months.
Paliperidone is a second-generation antipsychotic (SGA) or atypical antipsychotic medication that works in the brain to treat schizophrenia and schizoaffective disorder. It equalises dopamine and serotonin to improve thinking, mood, and behavior. Paliperidone is the primary active metabolite of risperidone. Its therapeutic activity in schizophrenia is mediated through a combination of central dopamine type 2 (D2) and serotonin type 2 (5HT2A) receptor antagonism.
It is available as a white to off-white sterile aqueous prolonged-release suspension for intramuscular injection. It is a once-monthly injectable that has demonstrated comparable efficacy as a first-generation long-acting injectable antipsychotic in decreasing disease severity and re-hospitalizations in schizophrenic patients. It also leads to significantly fewer extrapyramidal symptoms than other first-generation antipsychotic medications, indicating a superior safety profile.
At the recent SEC meeting for Neurology and Psychiatry held on May 12th, 2022, the expert panel reviewed the proposal for the import and manufacture of the Anti-psychotic drug Paliperidone Palmitate Prolonged Release Suspension for Intramuscular Injection 700mg & 1000mg.
After detailed deliberation, the committee noted that there is no unmet need and the firm should provide the following data:
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