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210365Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210365Orig1s000 OTHER REVIEW(S) MEMORANDUM REVIEW OF REVISED LABEL AND LABELING Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) Date of This Memorandum: June 20, 2018 Requesting Office or Division: Division of Neurology Products Application Type and Number: NDA 210365 Product Name and Strength: Epidiolex (cannabidiol) oral solution 100 mg/mL Applicant/Sponsor Name: GW Research Ltd FDA Received Date: June 20, 2018 OSE RCM #: 2018-114-2 DMEPA Safety Evaluator: Briana Rider, PharmD DMEPA Team Leader: Lolita White, PharmD 1 PURPOSE OF MEMORANDUM The Division of Neurology Products (DNP) requested that we review the revised container label and carton labeling for Epidiolex (Appendix A) to determine if they are acceptable from a medication error perspective. The revisions are in response to recommendations that we made during a previous label and labeling review.a 2 CONCLUSION The revised container label and carton labeling for Epidiolex are acceptable from a medication error perspective. We have no further recommendations at this time. a Rider, B. Human Factors Results and Label and Labeling Review Memorandum for Epidiolex (NDA 210365). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2018 JUN 15. RCM No.: 2018-114-1. 1 Reference ID: 4280945 APPENDIX A. IMAGES OF LABEL AND LABELING RECEIVED ON JUNE 20, 2018 Container label (b) (4) 2 Reference ID: 4280945 Carton labeling (b) (4) 3 Reference ID: 4280945 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ BRIANA B RIDER 06/21/2018 LOLITA G WHITE 06/21/2018 Reference ID: 4280945 MEMORANDUM REVIEW OF REVISED LABEL AND LABELING Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) Date of This Memorandum: June 15, 2018 Requesting Office or Division: Division of Neurology Products Application Type and Number: NDA 210365 Product Name and Strength: Epidiolex (cannabidiol) oral solution 100 mg/mL Applicant/Sponsor Name: GW Research Ltd FDA Received Date: May 18, 2018 OSE RCM #: 2018-114-1 DMEPA Safety Evaluator: Briana Rider, PharmD DMEPA Team Leader: Lolita White, PharmD 1 PURPOSE OF MEMORANDUM The Division of Neurology Products (DNP) requested that we review the revised container label, carton labeling, Prescribing Information (PI), Medication Guide (MG), and Instructions for Use (IFU) for Epidiolex (Appendix A) to determine if they are acceptable from a medication error perspective. The revisions are in response to recommendations that we made during a previous label and labeling review.a The Sponsor also proposes language in the PI and IFU for the introduction of a 1 mL oral syringe. 2 CONCLUSION The revised labels and labeling are unacceptable from a medication error perspective. We note the following statement under the “How should I take EPIDIOLEX?” section of the Medication Guide lacks clarity: “Measure each dose of EPIDIOLEX using the bottle adapter and dosing syringes that come with EPIDIOLEX”. We are concerned users may be confused if both 5 mL and 1 mL oral syringes are provided. a Rider, B. Human Factors Results and Label and Labeling Review for Epidiolex (NDA 210365). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2018 APR 27. RCM No.: 2018-114 and 2018-898. 1 Reference ID: 4278601 (b) (4) . (b) (4) 3 RECOMMENDATIONS FOR THE DIVISION A. Medication Guide 1. We note the following statement under the “How should I take EPIDIOLEX?” section of the Medication Guide lacks clarity: “Measure each dose of EPIDIOLEX using the bottle adapter and dosing syringes that come with EPIDIOLEX”.(b) (4) . To minimize the risk of wrong dose medication errors, we recommend revising the statement to read: “Measure each dose of EPIDIOLEX using the bottle adapter and 5 mL dosing syringes that come with EPIDIOLEX. If your dose of EPIDIOLEX is less than 1 mL, your pharmacist will provide you with 1 mL syringes to take your medicine.” 4 RECOMMENDATIONS FOR GW RESEARCH LTD We recommend the following be implemented prior to approval of this NDA: A. Carton labeling 1. (b) (4) B. Container label (b) (4) 1. 2 Reference ID: 4278601 APPENDIX A. IMAGES OF LABEL AND LABELING RECEIVED ON MAY 18, 2018 AND JUNE 14, 2018 A.1 List of Labels and Labeling Reviewed Using the principles of human factors and Failure Mode and Effects Analysis,b along with postmarket medication error data, we reviewed the following Epidiolex labels and labeling submitted by GW Research Ltd. Container label received on May 18, 2018 Carton labeling received on May 18, 2018 Instructions for Use (Image not shown) received on June 14, 2018 Prescribing Information (Image not shown) received on June 14, 2018 Medication Guide (Image not shown) received on June 14, 2018 b Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004. 3 Reference ID: 4278601 A. 2 Labels and Labeling Images Container label (b) (4) 4 Reference ID: 4278601 Carton labeling (b) (4) 5 Reference ID: 4278601 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ BRIANA B RIDER 06/15/2018 LOLITA G WHITE 06/15/2018 Reference ID: 4278601 Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research | Office of Surveillance and Epidemiology (OSE) Epidemiology: ARIA Sufficiency Templates Version: 2018-01-24 Date: June 12, 2018 Reviewer(s): Hongliu Ding, MD, PhD, MPH Division of Epidemiology I Team Leader: Kira Leishear, PhD, MS Division of Epidemiology I Division Deputy Director: Sukhminder K. Sandhu, PhD, MS, MPH Division of Epidemiology I Subject: ARIA Sufficiency Memo for Pregnancy Safety Concerns Drug Name(s): Epidiolex (Cannabidiol) Application Type/Number: NDA 210365 Applicant/sponsor: GW Research Ltd OSE RCM #: 2018-868 Page 1 of 5 Reference ID: 4277334 Expedited ARIA Sufficiency Template for Pregnancy Safety Concerns 1. BACKGROUND INFORMATION 1.1. Medical Product Epidiolex oral solution contains the active ingredient cannabidiol (CBD) and the proposed indication is for the adjunctive treatment of seizures associated with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) in patients 2 years and older. The precise mechanism of CBD anticonvulsant effect in humans is not clear. Although CBD interacts with cannabinoid receptors, it does not exert its anticonvulsant effects through this pathway 1. According to the Sponsor, CBD modulates intracellular calcium via GPR55 2, 3 and TRPV1 4, 5 channels and also modulates adenosine-mediated signaling 6-9, which might lead to reduced neuronal hyperexcitability and inflammation. 1.2. Describe the Safety Concern Epidiolex (Cannabidiol) exposure to females affected by Dravet or Lennox Gastuat syndromes who are pregnant or of childbearing potential is possible. However, as the sponsor stated, no studies have been conducted with cannabidiol in pregnant women. While pregnant women were excluded in the clinical trials, one pregnancy was reported 4 weeks after the last exposure in the cannabidiol clinical development programs, and the subject delivered ‘a full-term baby without complications’. In animal studies, the administration of cannabidiol up to a dose of 250 mg/kg/day in rats did not show adverse effects on fertility and early embryonic development, and a dose up to 75 mg/kg/day in a pre- and post-natal rat study did not observe adverse effects on offspring. Taken together, there are no adequate data on the developmental risk associated with the use of cannabidiol in pregnant women and the effect of cannabidiol on pregnancy outcomes is not known at this time. 1.3. FDAAA Purpose (per Section 505(o)(3)(B)) - Please ensure that the selected purpose is consistent with the other PMR documents in DARRTS Purpose (place an “X” in the appropriate boxes; more than one may be chosen) Assess a known serious risk Assess signals of serious risk Identify unexpected serious risk when available data indicate potential for serious risk x 2. REVIEW QUESTIONS 2.1. Why is pregnancy safety a safety concern for this product? Check all that apply. ☐ Specific FDA-approved indication in pregnant women exists and exposure is expected ☐ No approved indication, but practitioners may use product off-label in pregnant women Page 2 of 5 Reference ID: 4277334 ☒ No approved indication, but there is the potential for inadvertent exposure before a pregnancy is recognized ☒ No approved indication, but use in women of child bearing age is a general concern 2.2. Regulatory Goal ☒ Signal detection – Nonspecific safety concern with no prerequisite level of statistical precision and certainty ☐ Signal refinement of specific
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