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(Neurology and Psychiatry) Made in Its 53Rd Meeting Held on 27.11.2019 at CDSCO HQ New Delhi

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(Neurology and Psychiatry) Made in Its 53Rd Meeting Held on 27.11.2019 at CDSCO HQ New Delhi Recommendations of the SEC (Neurology and Psychiatry) made in its 53rd meeting held on 27.11.2019 at CDSCO HQ New Delhi. S. File Name & Drug Name, Firm Name Recommendations No. Strength New Drug Division 1. The committee deliberated the USFDA warning of serious immune system reaction with seizure and mental health medicine lamotrigine published in USFDA website on 12-03-/19-DC(Safety-004) 25.04.2018. Lamotrigine - After detailed deliberation the committee recommended that the immune system reaction called hemophagocytic lymphohistiocytosis (HLH) should be mentioned in the package insert leaflet of the drug lamotrigine marked in the country. 2. The firm presented their proposal before the committee. M/s Serdia 12-01/19-DC/PU-021 After detailed deliberation, the committee Pharm. (India) Tianeptine 12.5 mg Tablet recommended for approval of package insert as proposed except the change in proposed indication of major depressive episode. 3. The firm presented their package insert before the committee. 12-01/18-DC (Pt- 07)/PU- After detailed deliberation, the committee 037 M/s Johnson opined that the package insert should Methylphenidate HCl E.R. & Johnson contain the following warning: Tablet Tablets 18 mg / Pvt. Ltd. “To be sold by retail on the prescription of 36mg/54 mg Psychiatrist only.” The committee recommended for approval for other changes proposed by the firm. 4. The firm presented their package insert before the committee. 12-01/18-DC (Pt- 07)/PU- After detailed deliberation, the committee 024 M/s Johnson opined that the package insert should Paliperidone Palmitate & Johnson contain the following warning: Prolonged Release Pvt. Ltd. “To be sold by retail on the prescription of Suspension for injection Psychiatrist only.” 25/50/75/100 and 150 mg The committee recommended for approval for other changes proposed by the firm. Subsequent New Drugs Division 5. Firm presented the Phase III CT protocol before the committee. After detailed deliberation, committee noted gross errors in the Phase III CT 12-14/2014-DC (Pt-Rusan- protocol. Committee opined the following SND) M/s Rusan suggestions for further review by the Naltrexone tablet for implant Pharma committee: 765 mg 1. Sample size calculation needs to be carried out properly. 2. Operational definition of abstinence needs to be defined properly. 53rd EC (Neurology &Psychiatry) _27.11.2019 S. File Name & Drug Name, Firm Name Recommendations No. Strength 3. Lapse needs to be defined as well as measures for recording it needs to be incorporated. 4. Baseline investigations should include mandatory ECG recording as well as reporting by a qualified physician. 5. Serum amylase levels need to be carryout as well as USG whole abdomen. 6. Cognitive impairment needs to be excluded. 7. Assessment from the caregiver about consumption of alcohol may be serially taken at each visit. 8. Surgeon should be part of the study team to place the implant. 9. Residence of patients in hospital after implant shall be minimum for a period 3 days. 10. Whole methodology may be re-written including but not limited to hypothesis to be tested, concealment of allocation, measurement of compliance, type of analysis and presentation of confidence interval etc. Accordingly, the firm should submit the revised protocol for further review by the committee. 6. Firm presented the protocol of Active Post Marketing Surveillance of Aripiprazole Tablets 2mg before the committee. M/s Sun 12-66/2017-DC(Pt-Sun- Pharma After detailed deliberation, committee noted SND) Laboratories that the sample size appears inadequate and Aripiprazole tablets 2mg Limited the firm should recalculate the sample size. Accordingly, the firm should submit the revised Active PMS protocol. FDC Division 7. M/s. Roche Firm presented their proposal before the FDC/IMP/19/000014 Products committee and also showed the Registration Levodopa 200mg + (India) Pvt. certificate and Form 10 for proposed FDC Benserazide Hydrochloride Ltd. which is valid upto August 2021. 57mg eq. to Benserazide After, detailed deliberation the committee 50mg tablets recommended for grant of permission to import and market in the country. 8. M/s. Theon Firm presented their proposal before the 04-02/2019-DC(PSC-Theon) Pharmaceutica committee. After detailed deliberation the Gabapentin +Nortriptyline ls committee noted following observations: - (400mg+10mg) Film coated 1. The methods of randomization and tablets blinding are not given. 2. The definition of primary and 53rd EC (Neurology &Psychiatry) _27.11.2019 S. File Name & Drug Name, Firm Name Recommendations No. Strength secondary end points needs to be given in more details and justified. 3. Doses of Gabapentin need to be up- titrated over a period of two weeks. 4. The sample size given in the protocol is for two arm study where as the proposed study has three arm. A detailed calculation of the sample size needs to be justified. 5. The statistical analysis plan is inadequate the firm should present detailed statistical analysis plan. 6. The justification not given for combining of these two drugs in the proposed dosage form. Accordingly, the firm should revise the Clinical Trial protocol and present before the committee. GCT Division 9. CT/67/17 M/s. Medpace The firm presented the proposed protocol Ataluren amendment before the committee. After detailed deliberation, the committee recommended for approval of the modified protocol as presented. 10. CT/78/19 M/s. CliniRx The firm presented the SAE details related Evenamide with 5 cases of overdose as per their (NW-3509) company policy and this amendment needs to be incorporated in all the ongoing clinical trials. After detailed deliberation the committee recommended for grant of permission to conduct the study with the above amendment. The Committee has also given advisory that administration of medication needs to be strictly supervised in all the study sites in India. 11. CT/79/19 M/s. CliniRx The firm presented the SAE details related Evenamide with 5 cases of overdose as per their (NW-3509) company policy and this amendment needs to be incorporated in all the ongoing clinical trials. After detailed deliberation the committee recommended for grant of permission to conduct the study with the above amendment. The Committee has also given advisory that administration of medication needs to be 53rd EC (Neurology &Psychiatry) _27.11.2019 S. File Name & Drug Name, Firm Name Recommendations No. Strength strictly supervised in all the study sites in India. 12. CT/86/19 M/s. CliniRx Firm presented their proposal before the Evenamide committee. (NW-3509) Assessment of risk vs. Benefit to the patients: The safety profile of the study drugs from preclinical toxicology studies including Single-Dose Toxicity, repeat dose toxicity, Phase I & II clinical study justify the conduct of the trial. Innovations Vs Existing Therapeutic Option: To evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid) in patients with treatment-resistant schizophrenia not responding adequately to a stable, therapeutic doses of their current antipsychotic medication. Unment Medical Need In The Country: Treatment of patients with treatment- resistant schizophrenia not responding adequately to a stable, therapeutic doses of their current antipsychotic medication. After detailed deliberation the committee recommended for grant of permission to conduct the study. The committee has also given advisory for documentation of failure of two adequately dose antipsychotic drugs for a duration of 6 weeks each needs to be carefully done. 53rd EC (Neurology &Psychiatry) _27.11.2019 .
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