There is no unmet need: CDSCO Panel rejects J&J proposal to Import and manufacture Paliperidone Palmitate

Published On 2022-05-29 05:59 GMT | Update On 2022-05-29 05:59 GMT

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:

1. Data of Global & ethnic Indian (or Indian origin) patients on the comparative efficacy of PP6M Vs PP3M and PP6M Vs PP1M.

2. The name of the countries where 6 months injection (PP6M), has approved without the approval of 3 months injections (PP3M).

Also Read:AstraZeneca gets CDSCO nod to conduct Phase III CT of antineoplastic FDCs drug

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

There is no unmet need: CDSCO Panel rejects J&J proposal to Import and manufacture Paliperidone Palmitate

Similar News

Roche gets negative EMA Committee opinion on Elevidys CMA for 3-7 year olds with Duchenne muscular dystrophy

Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First

Menopause relief drug: USFDA extends review period for Bayer Elinzanetant

Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease

Troikaa's Fast-Acting Paracetamol Shot Hits Regulatory Hurdle, CDSCO Panel Seeks More Data

Sanofi Sarclisa approved in EU for transplant-eligible newly diagnosed multiple myeloma

Pharma Firm Ignored Safety Gaps Before Deadly Blast, Paid Rs 32 Cr To Victims, Parliament Informed

GSK Blenrep combos approved in EU for treatment of relapsed/refractory multiple myeloma