- Preliminary data indicate extensive and rapid absorption of
OX125 across all formulations
- Positive results underline the applicability of Orexo's
novel intranasal drug delivery platform
UPPSALA, Sweden, June 30, 2020 /PRNewswire/ -- Orexo AB (publ.),
(STO:ORX) (OTCQX:ORXOY), today announces positive results
from its human pharmacokinetic (PK) study of OX125. The study was a
cross-over, comparative bioavailability study in healthy volunteers
to assess nalmefene absorption from three development formulations
of OX125, Orexo's wholly-owned nasal nalmefene product, compared to
a nalmefene intramuscular injection. Preliminary results indicate
extensive and rapid absorption across all three OX125 formulations
as well as good tolerability, supporting the viability of OX125 as
a rescue medication for opioid overdose.
Highly potent synthetic opioids, such as fentanyl, have become
the leading cause of death following drug overdoses in the US with
over 31,000 fatalities in 2018.1 Like naloxone,
nalmefene is an opioid antagonist that acts by blocking the effects
of opioids at the opioid receptors. Nalmefene also has a longer
half-life than naloxone, giving an extended duration of the opioid
blockade. Therefore, nalmefene could be an effective response to
the increased use of potent, long-acting synthetic opioids such as
fentanyl. The longer-acting properties of nalmefene may also be of
particular value to protect against renarcotization (second
overdose), as the antagonist wears off.
Robert Rönn, VP and Head of R&D, at Orexo,
said: "I am pleased with the results from this important
clinical study as well as the timely delivery from Orexo's R&D
team. This is not only a proof-of-concept for our wholly-owned
OX125 product, but also a demonstration of the value of our novel
nasal technology platform. We will now set forth to engage with US
Food and Drug Administration, FDA, to identify the optimal route to
market."
"As the US heroin crisis has developed to a fentanyl crisis, the
medical need for novel and more powerful opioid rescue medications
is vast. The need has also escalated further due to the COVID-19
pandemic as the consequences of social distancing and economic
weakness are expected to lead to a significant increase in mental
health issues and substance use disorders. Alongside OX124, our
naloxone rescue project, OX125 will be an important lifesaving
addition in our commitment to helping patients suffering from
opioid addiction in all phases. I am encouraged by the results from
our R&D team and look forward to the continued development of
this pharmaceutical product," said Nikolaj Sørensen, President
and CEO.
The addressable market for OX125 and OX124 is large and growing
as demand for easy to use, potent overdose reversal medication
increases, not only for emergency staff and first responders, but
also for opioid dependent patients, and as co-prescription for
high-dose opioid pain patients. According to Orexo's estimates,
greater levels of co-prescriptions and expanding access for opioid
dependent patients may increase the market size from today's
USD 300-500 million to USD 1.5-2
billion. The combined estimated sales potential for OX125 and OX124
amounts to USD 110-170 million five years post launch, where
the majority refers to OX124.
About Orexo
Develops improved pharmaceuticals and digital therapies
addressing unmet needs within the growing space of substance use
disorders and mental health. The products are commercialized by
Orexo in the US or via partners worldwide. The main market today is
the American market for buprenorphine/naloxone products, where
Orexo commercialize its lead product Zubsolv® for treatment of
opioid use disorder. Total net sales for 2019 amounted to
SEK 844,8 million and the number of
employees was 127. Orexo is listed on the Nasdaq Stockholm Mid Cap
(ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The head
office, where research and development is also performed, is
situated in Uppsala, Sweden.
For more information about Orexo please visit, www.orexo.com.
You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn and
YouTube.
About OX125
OX125 is a nasal nalmefene rescue medication under development
by Orexo. The substance is a full opioid receptor antagonist that
reverses the effects of opioid agonists, including the life
threatening respiratory depressant effects occurring in an opioid
overdose. Nalmefene is a more potent and longer acting antagonist
compared with naloxone that may increase the possibility of
survival for specific target groups. OX125 is based on Orexo's
nasal technology platform developed to provide rapid and effective
absorption of drug substances through the nasal mucosa.
About OX124
OX124 is based on a novel and unique technology developed to
provide a rapidly acting naloxone rescue medication with the aim to
provide differentiated profile compared to currently marketed
products and other products under development. Naloxone is a
full opioid receptor antagonist which reverses the effects of
opioid agonists, including the life threatening respiratory
depressant effects occurring in an opioid overdose.
Results from the exploratory PK-study in healthy
volunteers showed substantially higher plasma concentrations of
naloxone, sustained duration of elevated plasma concentrations, and
equivalent or superior onset time, when compared to the market
leading product.
The information was submitted for publication, through the
agency of the contact persons set out above, at 8.00 am CET on June 30,
2020.
Reference:
1 National Institute of Drug Abuse
For more information please contact:
Orexo AB
(publ.)
Nikolaj Sørensen, President and CEO
Tel: +46 18 780 88 00
E-mail: ir@orexo.com
Robert Rönn, VP and Head of R&D
Tel: +46 18 780 88 00
E-mail: ir@orexo.com
Lena Wange, IR &
Communications Director
Tel: +46 18 780 88 00
E-mail: ir@orexo.com
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/orexo/r/positive-results-from-human-pk-study-assessing-orexo-s-intranasal-nalmefene-formulations-for-opioid-,c3144721
The following files are available for download:
https://mb.cision.com/Main/694/3144721/1271750.pdf
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Orexo Press Release
Positive results from OX125 human PK study
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