Regulatory Story
Go to market news section View chart   Print
Company Reckitt Benckiser Group PLC
TIDM RB.
Headline

RBP voluntarily discontinue supply of Suboxone® Tablets

Released 08:34 25-Sep-2012
Number 20831-1053

RBP voluntarily discontinue supply of Suboxone® Tablets

Reckitt Benckiser Pharmaceuticals Inc. to                   
            Voluntarily Discontinue the Supply of Suboxone® Tablets            
            (buprenorphine and naloxone sublingual tablets [CIII])             

In response to a number of queries from stakeholders, RB confirms that Reckitt
Benckiser Pharmaceuticals Inc. confirms that it notified the U.S. Food and Drug
Administration (FDA) on September 18, 2012 that the company is voluntarily
discontinuing the supply of Suboxone Tablets (buprenorphine and naloxone
sublingual tablets [CIII]) due to increasing concerns with pediatric exposure.
The company received an analysis of data from U.S. Poison Control Centers on
September 15, 2012 that found consistently and significantly higher rates of
accidental unsupervised pediatric exposure with Suboxone® Tablets
(buprenorphine and naloxone sublingual tablets [CIII]) than seen with Suboxone®
Film (buprenorphine and naloxone sublingual film [CIII]).  The rates for
Suboxone Tablets were 7.8 - 8.5 times greater depending on the study period.

While the data do not isolate the root cause of these findings, the unique
child resistant, unit-dose packaging of the next generation Suboxone Film is
believed to be one of the key contributing factors to the decrease in exposure
rates compared to Suboxone Tablets that are distributed in a multi-dose bottle
containing 30 tablets, since the active ingredients of both products are the
same. Other factors may include Reckitt Benckiser Pharmaceuticals' community
and healthcare professional educational initiatives in addition to the
company's Risk Evaluation and Mitigation Strategy program.

Reckitt Benckiser Pharmaceuticals is working closely with the FDA and the
broader healthcare community to ensure patients currently taking Suboxone
Tablets have sufficient time and notification to appropriately transition to
the same effective active ingredient with Suboxone Film to minimize any risk to
the continuity of their treatment. We anticipate that distribution of Suboxone
Tablets will be discontinued within the next six months, possibly sooner
depending on discussions with the FDA.

The pediatric exposure safety issue is not related to the active ingredients
found in both Suboxone Tablets and Suboxone Film. The company encourages
patients currently taking Suboxone Tablets to continue with their treatment and
consult their physician about how to transition to Suboxone Film. Suboxone Film
is covered by the majority of insurance plans, Medicare and Medicaid.
Additionally, patients can access a savings program at Suboxone.com or from
their physician to offset out-of-pocket costs associated with their medication.
Since the U.S. launch of Suboxone in 2003, it is estimated that over three
million Americans with opioid dependence have been treated with the safe and
effective active ingredients in Suboxone Tablets and Suboxone Film,
buprenorphine and naloxone.

For further information:

Investor enquiries, contact:

Richard Joyce, RB +44(0)1753 217800

Press enquiries, contact:

Andraea Dawson-Shepherd, RB +44 (0)1753 446 447


David Litterick, Brunswick +44 (0) 207 7396 7455

Close


London Stock Exchange plc is not responsible for and does not check content on this Website. Website users are responsible for checking content. Any news item (including any prospectus) which is addressed solely to the persons and countries specified therein should not be relied upon other than by such persons and/or outside the specified countries. Terms and conditions, including restrictions on use and distribution apply.

 


RBP voluntarily discontinue supply of Suboxone® Tablets - RNS