AUTH/2235/5/09: ProStrakan’s Abstral ad implied faster onset (“Acts in minutes”) and breached an undertaking

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Key facts

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Case number	AUTH/2235/5/09
Parties	Cephalon/Director v ProStrakan
Product	Abstral (sublingual fentanyl citrate tablet)
Material/channel	BMJ advertisement (18 April 2009), ref MO17/0134; date of preparation March 2009
Main claims at issue	“To hell and back in minutes”; “Acts in minutes”; also “Dissolves in seconds. Acts in minutes”
SPC timing referenced by Panel	Relief from 15 minutes after administration onwards (SPC 5.1); dosing guidance 15–30 minutes (SPC 4.2)
Applicable Code year	2008
Breach clauses	2, 3.2, 7.2, 9.1 and 25
Complaint received	28 May 2009
Undertaking received	3 July 2009
Appeal hearing	No appeal by either party; Panel referred to the Appeal Board
Appeal Board considerations	23 July 2009; 24 February 2010; 22 July 2010
Interim case report published	26 August 2009
Case completed	22 July 2010
Sanctions applied	Undertaking received; Advertisement; Audit of company’s procedures; Re-audit

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

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Cephalon complained about a revised UK promotional campaign for Abstral (sublingual fentanyl citrate tablet) issued by ProStrakan, following an earlier PMCPA ruling against a “from 10 minutes” pain relief claim (Case AUTH/2207/2/09).
The BMJ advertisement (18 April 2009; ref MO17/0134; date of preparation March 2009) used the headline “To hell and back in minutes” and the claim “Acts in minutes” (also used unreferenced in the strapline).
The Abstral SPC stated pain relief was shown from 15 minutes after administration onwards (SPC section 5.1) and dosing guidance referred to 15–30 minutes (SPC section 4.2).
The Panel considered that “in minutes” would commonly be read as less than 15 minutes (and potentially less than 10), especially alongside the wording “Dissolves in seconds. Acts in minutes” and the visual depiction of rapid relief.
Because the complaint alleged non-compliance with an earlier undertaking, the Director also pursued that aspect (Clauses 2 and 9.1 considered in addition to those cited by Cephalon).

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The Panel ruled the claims were misleading and inconsistent with the SPC.
The Panel ruled the new claims were sufficiently similar to the previously ruled claim and therefore breached the undertaking.
The Panel considered the matter serious enough to report ProStrakan to the Code of Practice Appeal Board (Paragraph 8.2 of the Constitution and Procedure).
The Appeal Board required an Authority audit, then a re-audit; after the re-audit it decided no further action was required.

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