Sativex (Tetranabinex and Nabidiolex) - Qualifying Notice

2007-08-01

Contact: BCANS Enquiries

Therapeutic Products Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
Ottawa, Ontario
K1A 0K9

9427-G0846/1-21

June 7, 2007

[employee name removed]
Director of Regulatory Affairs
GW Pharmaceuticals Ltd.
Porton Down Science Park,
Salisbury, Wiltshire
SP4 0JQ
United Kingdom

NOTICE OF COMPLIANCE WITH CONDITIONS - QUALIFYING NOTICE

Dear [employee name removed]:

This Notice of Compliance with conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the Supplemental New Drug Submission for SATIVEX®(Delta-9-tetrahydrocannabinol (from Tetranabinex® - Cannabis sativa L. extract) / Cannabidiol (from Nabidiolex® - Cannabis sativa L. extract), buccal spray), Control Number 109461, for its use as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain, qualifies to be considered for authorization under the NOC/c Policy. In keeping with the provisions outlined in the NOC/c Policy, the following additional information is required to complete the assessment:

  1. A letter signed by the Chief Executive Officer, or designated signing authority of GW Pharmaceuticals Ltd., indicating that you agree to have this submission considered under the NOC/c Policy. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, GW Pharmaceuticals Ltd. consents to the posting of the NOC/c-QN on Health Canada's website.

  2. A draft Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority of GW Pharmaceuticals Ltd, having a form and content satisfactory to Health Canada, as indicated in the Guidance for Industry: Notice of Compliance with Conditions, including commitments to provide the following:

    1. Protocols for two well designed and controlled studies in adult patients with advanced cancer who experience moderate to severe pain (≥ 4 on the 11-point Numerical Rating Scale) during the highest tolerated dose of strong opioid therapy for persistent background pain. The proposed studies should confirm the promising efficacy results of the preliminary study. The confirmatory studies are expected to evaluate the safety and efficacy of SATIVEX® under the proposed conditions of use as an adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain (≥ 4 on the 11-point Numerical Rating Scale) during the highest tolerated dose of strong opioid therapy for persistent background pain. These studies should also employ established, clinically meaningful and validated efficacy outcome measures; and should be of sufficient power to provide clinically and statistically significant efficacy results.

      The confirmatory studies are expected to use only strong opioids for persistent background pain,listed as World Health Organization (WHO) Step III strong opioids (pure opioid receptor agonists).

      Safety data from these studies should include the evaluation of routine safety outcomes related to the SATIVEX® treatment. The safety data should also include the evaluation of all safety outcomes specific to the use of SATIVEX® and other emerging safety issues.

      The confirmatory studies should be initiated within a timeframe that is agreed upon between Health Canada and GW Pharmaceuticals Ltd.

    2. Additional long-term data from ongoing open extension studies or studies completed after filing this SNDS, which demonstrate the duration / extent of maintenance of treatment benefit and safety of long-term treatment, should be submitted as they become available.

    3. Periodic Safety Update Reports - for NOC/c Products (PSUR-Cs) on a semi-annual basis. PSUR-Cs should be prepared in accordance with ICH Guidelines and should include events reported for SATIVEX® under this NOC/c. PSUR-Cs should be submitted in paper and electronic (bookmarked and searchable) formats.

    4. Reports of all serious Adverse Reactions (ARs) that occur in Canada and all serious unexpected ARs that occur outside of Canada should be forwarded within 15 days to Health Canada. One copy should be provided to the Marketed Health Products Directorate and another copy to the Bureau of Cardiology, Allergy and Neurological Sciences in the Therapeutic Products Directorate in accordance with current regulations and guidelines.

    5. Notification and reporting on specific issues of concern as outlined in Section 6.2.4 of the Guidance for Industry, Notice of Compliance with Conditions.

    6. Additional information to be provided in the draft Letter of Undertaking includes an outline of agreed-upon advertising, labelling or distribution requirements; a complete listing of ongoing additional clinical trials (appended to the draft Letter of Undertaking); copies of any marketing approvals for SATIVEX® from any other drug regulatory authority; and a commitment to provide a revised Product Monograph as new information is made available.

  3. A draft "Dear Healthcare Professional Letter" detailing the issuance of a Notice of Compliance under the NOC/c Policy for SATIVEX® when used as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.

  4. A draft "Fact Sheet" outlining in lay language the potential risks, benefits, and side effects of SATIVEX® when used as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.

  5. A draft Product Monograph which is consistent with the requirements outlined in Section 5.2.1 of the Guidance for Industry, Notice of Compliance with conditions. Please note that, if applicable, a boxed text must appear on the cover page, at the beginning of each major section of the Product Monograph (Parts I, II and III), disclosing the nature of the authorization granted for SATIVEX® and the need to conduct confirmatory studies.

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance and policy on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to Guidance for Industry: Notice of Compliance with Conditions) to the outstanding information within 30 calendar days of the date of this letter.

In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to: Submission and Information Policy Division, Therapeutic Products Directorate, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Ottawa, Ontario, K1A 0K9.

Yours sincerely,

Original signed by

Supriya Sharma, MD MPH FRCPC
Acting Director General

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