ProStrakan v Cephalon: Effentora titration booklet—misleading efficacy graphic and SPC-inconsistent administration images

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Key facts

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Case	AUTH/2216/3/09
Parties	ProStrakan v Cephalon
Product	Effentora (fentanyl buccal tablet)
Material	“Titration Guidelines” booklet (ref CE/FE-08031/Dec08)
Therapy area	Breakthrough cancer pain (BTcP) in opioid-tolerant patients
Complaint received	11 March 2009
Case completed	6 May 2009
Applicable Code year	2008
Breach clauses	3.2 and 7.8
No appeal	Yes
Sanction	Undertaking received

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

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ProStrakan complained about Cephalon’s promotional “Titration Guidelines” booklet for Effentora (fentanyl buccal tablet) used for breakthrough cancer pain (BTcP) in opioid-tolerant patients.
The booklet front cover claimed: “A dose for each BTcP patient. With a range of 5 doses, Effentora allows you to individualise the treatment of BTcP”.
The front cover also included a descending red scale from “10 minutes” to “0”, superimposed on an image of a relaxed, happy couple.
The booklet included diagrams showing where to place tablets in the mouth for different doses; for 600mcg and 800mcg some tablets appeared positioned in the lower buccal cavity.
ProStrakan also challenged whether prescribing information adequately presented application site reaction frequency.
A further allegation was that Cephalon’s corporate strapline “deliver more” (near the product logo) was a “hanging comparison”.

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No breach for the claim “A dose for each BTcP patient…” (Clauses 7.2 and 7.4 not breached).
Breach for the descending “10 minutes to 0” scale on the cover: it could imply complete pain relief in 10 minutes (Clause 7.8).
No breach for the corporate strapline “deliver more” being a hanging comparison (Clause 7.2 not breached).
Breach for tablet-placement diagrams being inconsistent with the Effentora SPC (Clause 3.2).
No breach regarding omission of frequency for application site reactions in prescribing information (Clauses 4.2 alleged; no breach of Clause 4.1 ruled).

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