was founded in 1995 by Thomas Lundqvist, a pharmacist,
Anders Pettersson, a physician and clinical pharmacologist , and
Christer Nyström, a pharmacist and Professor of Galenic
Pharmacy at Uppsala University.
The company’s first product, Diabact® UBT – a breath test for diagnosing the
stomach ulcer bacterium, Helicobacter pylori – was registered in
The name Orexo
In 2003 the company adopted the name Orexo, which derives from Greek and is
the future form of the verb "orégo" - "to attain, to extend." Orexo also means
appetite. New shareholders contributed financing, thereby raising the level of
activity in the company. New development projects were started and a new company
management was appointed to lead the company into the next phase.
In 2005, Orexo was listed on the Stockholm Stock Exchange. The company has
since then entered into agreements with business partners and the development
portfolio includes several potential drug candidates.
EU launch of Abstral®
Abstral was approved for the treatment of breakthrough cancer pain during
2008. The product was launched in Sweden in August 2008 via the joint-venture
company ProStrakan AB. In early 2009, Orexo’s partner, Prostrakan, launched
Abstral in the UK and Germany.
Launch of Edluar®
In March 2009, the U.S. Food and Drug Administration, FDA, approved Edluar
for the treatment of short-term insomnia. Orexo’s global partner Meda launched
the product on the US market in August 2009.
Stronger ownership base
During 2010 Novo A/S became a new principal owner of Orexo.
Launch of a new strategy and new development program
In August 2010 the next stage of the strategy was launched: the use of
proprietary, patented and proven technologies to develop new proprietary
products within the specialty pharma segment. As part of this strategy Orexo
initiated three new development programs with the aim of marketing the products
through the company’s own marketing and sales organization, with focus on the
Abstral launched in a number of EU countries
During 2010 Abstral was launched in a further 12 countries in Europe.
US approval of Abstral®
During 2011 Abstral was approved by the U.S. Food and Drug Administration,
FDA. The product was launched by ProStrakan in the USA.
Abstral® approved in Canada
Abstral was approved in Canada in 2011.
Renegotiated agreement with ProStrakan
In June 2012 Orexo acquired the commercial rights for Abstral in the USA
while ProStrakan acquired the rights in the EU and the rest of the world.
Submission of New Drug Application for Zubsolv®
In September 2012 a New Drug Application was submitted in the USA for Zubsolv
for the treatment of opioid dependence.
Abstral in the United States sold to Galena Biopharma, Inc.
In March 2013, Orexo sold Abstral (fentanyl) Sublingual Tablets in the
United States to Galena Biopharma, Inc.
Abstral approved in Japan
Abstral was approved for sales in Japan in September 2013 and was
launched in December by Kyowa Hakko Kirin.
Edluar launched in a number of EU countries
During 2013 Edluar was launched by Orexo's global partner MEDA in a number of European countries.
US approval of Zubsolv
On July 3, 2013, FDA approved Zubsolv for the maintenance treatment of opioid
Application for expanded label of Zubsolv to include initiation of treatment
On October 10, 2014 Orexo submitted an application to the FDA for an expanded label for Zubsolv to include initiation of treatment for opioid dependence.
Two new higher strengths of Zubsolv approved in the US
The FDA announced on December 11, 2014 the approval of two new higher tablet strengths of Zubsolv sublingual buprenorphine/naloxone: 8.6-mg/2.1-mg and 11.4-mg/2.9-mg.
Orexo divests the subsidiary Kibion
On April 30, 2015, Orexo divested the subsidiary Kibion. The acquirer is a
team of Swedish investors and business developers with a solid background in the
fields of diagnostics and treatment of gastroenterological diseases.
U.S. FDA approves Zubsolv for induction of maintenance treatment
On August 10, 2015, FDA approved Zubsolv for induction of maintenance therapy in patients with opioid dependence.