· Mundipharma and Orexo make first EU regulatory submission for Zubsolv®
(buprenorphine and naloxone) sublingual tablet
· Zubsolv was approved in the US in 2013 for the maintenance treatment of
opioid dependence, as part of a complete treatment plan
· Opioid dependence represents a significant public health problem; across
Europe there are an estimated 1.3 million high-risk opioid users
Cambridge, UK and Uppsala, Sweden– 4 October, 2016 Mundipharma and Orexo AB
(publ.) have announced the submission of a regulatory submission of a Marketing
Authorisation Application (MAA) for Zubsolv (buprenorphine and naloxone)
sublingual tablet to the European Medicines Agency (EMA), seeking approval for
the treatment of opioid dependence. If approval is received, the buprenorphine
and naloxone sublingual tablet would be the first fast dissolving buprenorphine
and naloxone product available in six unique strengths for the treatment of
opioid dependence in Europe.
Mundipharma and Orexo have worked in partnership to complete the submission and
the required bio-equivalence study, comparing Zubsolv to Suboxone® European
buprenorphine and naloxone tablets. The pre-submission meeting with the
Rapporteur agreed that the results of the bioequivalence study along with
supporting data from previous pharmacokinetic studies performed and Orexo’s
extensive clinical program, including data on more than 1,000 opioid dependent
patients, were suitable to move forward with the regulatory filing. In addition,
Zubsolv has been approved in the US since July 2013 and has resulted in more
than 37 million tablets prescribed to date and greater than 44,000 patient
year’s exposure, providing additional reassurance of product efficacy and
safety.
Similar to previous studies comparing Zubsolv to Suboxone US Tablet and film
formulations the participants in the European study showed strong preference for
Zubsolv. When compared with the Suboxone European tablet, Zubsolv was preferred
by 77.0 percent (low dose) and 79.4 percent (high dose) of the subjects and the
tablet dissolve times were faster for Zubsolv than for Suboxone.
The submission will not trigger any new financial milestones. However
Mundipharma is compensating Orexo for specific expenses related to the work
required to prepare the submission. The next milestones are pending marketing
authorisations and commercialisation of Zubsolv. Orexo is also entitled to
receive tiered royalties on future net sales.
Nikolaj Sørensen, CEO and President of Orexo AB, said: “With the regulatory
filing to EMA of Zubsolv, Orexo has met another major milestone in the efforts
to potentially make Zubsolv available for patients world-wide. Opioid dependence
is a growing concern globally and with the unique novel product characteristics
of Zubsolv such as fast dissolve time, six unique strengths to suit individual
patients’ needs and strong patient preference, I am certain Zubsolv could be a
welcome alternative for European physicians treating opioid dependence. I am
very pleased with the first concrete results of the collaboration with
Mundipharma and I am looking forward to working with them to make Zubsolv
available in many more countries globally.”
Rachel Gooch, Head of Addiction Therapy, Mundipharma International Limited,
said: “We are pleased to submit Zubsolv to the EMA for marketing authorization
and take a further significant step in our collaboration with Orexo. Opioid
dependency is a chronic condition that places a disproportionately large burden
on individuals and societies across Europe as well as globally. We are committed
to working to support people living with opioid use disorders to have the best
possible chance to work towards positive change.”
For more information, please contact:
Mundipharma Orexo AB
(publ.)
Rachel Gooch, Head of Addiction Therapy Nikolaj
Sørensen,
CEO and
President
Tel: +44 (0)1223 397 453 Tel: +46
(0)18
780 88 00
Email: Email:
rachel.gooch@mundipharma.co.uk (rachel.gooch@mundipharma.co.uk) ir@orexo.com
MHP Communications
Madeleine Harris Smith
Tel: +44 (0)20 3128 8810
Email: madeleine.harrissmith@mhpc.com
About Mundipharma
Mundipharma and its network of independent associated companies are privately
owned companies and joint ventures covering the world's pharmaceutical markets.
These companies are committed to bringing to patients the benefits of
significant new treatment options in the core therapy areas of pain,
respiratory, addiction, oncology and inflammatory conditions. Through
innovation, design and acquisition, Mundipharma delivers important treatments to
meet the most pressing needs of patients, healthcare professionals and health
systems worldwide.
For further information please visit: www.mundipharma.com
About Orexo
Orexo is a specialty pharmaceutical company commercializing its proprietary
product Zubsolv® for treatment of opioid dependence in the US. Zubsolv is an
advanced formulation of buprenorphine and naloxone using Orexo’s unique
knowledge and expertise in sublingual drug delivery. R&D is focusing on
reformulation of known substances to new improved products that meet great unmet
medical needs by using its patented proprietary technologies. Orexo’s share is
listed on Nasdaq Stockholm Exchange Mid Cap (STO:ORX) and is available as ADRs
on OTCQX (ORXOY) in the US. Orexo’s global headquarters and R&D are based in
Uppsala, Sweden.
For more information about Orexo please visit www.orexo.com
This information is information that Orexo AB (publ.) is obliged to make public
persuant to the EU Market Abuse Regulation. The information was submitted for
publication, through the agency of the contact persons above at 8.00 am CET on
October 4, 2016
Mundipharma and Orexo announce EU regulatory submission for Zubsolv®
| Quelle: Orexo AB
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