ProStrakan breach for ‘rapid relief from 10 minutes’ claim for Abstral

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Key facts

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Case number	AUTH/2207/2/09
Case reference	Cephalon v ProStrakan (Promotion of Abstral)
Complainant	Cephalon (UK) Limited
Respondent/company	ProStrakan Ltd
Product(s)	Abstral (sublingual fentanyl citrate tablet)
Material/channel	Two leavepieces (MO17/0070 and MO17/0101)
Key issue	Claim “Rapid relief of breakthrough cancer pain from 10 minutes” inconsistent with Abstral SPC (SPC supported significant relief from 15 minutes onwards)
Dates (received/completed if stated)	Received 11 February 2009; completed 16 March 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 3.2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Cephalon (UK) Limited complained about ProStrakan Ltd’s promotion of Abstral (sublingual fentanyl citrate tablet).
The materials at issue were two leavepieces (refs MO17/0070 and MO17/0101).
The claim challenged was: “Rapid relief of breakthrough cancer pain from 10 minutes”.
The claim was referenced in the leavepieces to “data on file” (Study EN3267-005).
Cephalon alleged the claim was inconsistent with the Abstral summary of product characteristics (SPC), which stated significantly superior relief versus placebo from 15 minutes after administration onwards.
ProStrakan argued the claim was supported by Phase III study EN3267-005 data and was referenced as such in the materials.

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The Panel ruled that the “from 10 minutes” claim, although based on study EN3267-005, was inconsistent with the particulars listed in the Abstral SPC.
The Panel ruled a breach of Clause 3.2 of the Code.
Complaint received: 11 February 2009.
Case completed: 16 March 2009.

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