AUTH/2961/6/17: Indivior v Martindale — Espranor website promoted to the public and “no diversion/instant disintegration” claims ruled misleading | PMCPA Case

📊

Key facts

⌄

Case	AUTH/2961/6/17
Parties	Indivior v Martindale Pharmaceuticals Limited
Product(s)	Espranor (buprenorphine oral lyophilisate); comparator referenced: Subutex (buprenorphine sublingual tablets)
Therapy area	Substitution treatment for opioid drug dependence
Materials	Two detail aids (ADD/11/2016/122; ADD/01/2017/130), patient leaflet (ADD/12/2016/127), website (ADD/01/2017/133)
Main issues	Promotion to the public via open website; misleading/over-absolute claims on diversion, disintegration, supervision time; misleading comparisons with Subutex; safety profile claims; prominence/omission of non-interchangeability warning
Applicable Code year	2016
Complaint received	26 June 2017
Case completed	2 January 2018
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

Indivior complained about Martindale’s promotion of Espranor (buprenorphine oral lyophilisate) versus Indivior’s Subutex (buprenorphine sublingual tablets).
Materials at issue: two detail aids (“Product Overview (ADD/11/2016/122)” and “Straight to the Point (ADD/01/2017/130)”), a patient leaflet (ADD/12/2016/127) and an open-access website (www.espranor.com; ADD/01/2017/133).
The Espranor website landing page was visible to anyone and included claims such as “novel formulation… allows instant disintegration and rapid dissolution…”. A “NOT a healthcare professional” pathway led to a page for “patients interested in opioid substitution therapy and Espranor”.
Indivior alleged the website promoted a prescription-only medicine to the public and encouraged patients to request Espranor, without adequate safety balance (notably non-interchangeability warnings).
Indivior also challenged multiple claims across materials implying: no diversion/“impossible to remove”, “instant disintegration”, “eliminates the opportunity for removal”, reduced/minimised supervision time, and comparisons with Subutex dissolution time.
Indivior challenged “equivalent/comparable safety” claims given higher reported mild adverse events with Espranor in the cited study data.

⚖️

⌄

Breaches ruled for promotion of a POM to the public via an open-access homepage and patient-facing content that encouraged seeking a prescription.
Breaches ruled for misleading, over-dogmatic and unsubstantiated claims about diversion (“No diversion”, “impossible to remove”), “instant disintegration”, and “eliminating” opportunity for removal.
Breaches ruled for misleading comparisons with Subutex (including “up to 10 minutes” framing and charts not fairly reflecting the Subutex SPC range) and for claims about reduced/minimised supervision time.
Breaches ruled for “equivalent/comparable safety” claims that were not a fair reflection of adverse event data (notably higher mild AEs with Espranor).
Breaches ruled for high standards (Clause 9.1) including insufficient prominence/positioning of non-interchangeability warnings in certain materials and on the website (health professional section), and omission of similar warning from the patient leaflet.
Clause 2 breach ruled due to cumulative effect prejudicing patient safety/public health in a vulnerable patient population.
No breach rulings were made on some points, including: Clause 7.6 (complaint not validly particularised), certain Clause 7.9 allegations (where not relevant), one “barriers” statement in a detail aid (not read as a comparison in context), and the patient leaflet not needing safety data given its limited “how to administer” purpose.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access