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InViva™
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For the Treatment of Anxiety Disorders
There is a serious need for a safe and effective pharmaceutical treatment for
chronic anxiety. The market potential for a patent protected, branded
medication for the treatment of chronic anxiety that is substantially superior
to existing alternatives with regard to efficacy, safety, reduction of side
effects, and long-term use is substantial.
According to the National Institute of Mental Health, 28.8% of the adult
U.S. population will suffer from an anxiety disorder.2 Moreover, there is
growing evidence that chronic stress and anxiety are leading factors that
contribute to the development of chronic medical problems, from
Alzheimer’s to cardiovascular disorders, which have enormous
consequences for the individual, their family, and our health system.
Specific anxiolytic medications, including the popular benzodiazepines,
while often effective for acute anxiety, are well known for noxious side
effects including sedation, memory and other cognitive impairments,
hyperexcitability, tolerance, withdrawal symptoms and dependence.
Therefore, they are not clinically appropriate or indicated for chronic anxiety
or long-term use.3 Moreover, the patents for the most popular of these
medications (Zanex, Prozac and Valium) expired years ago, and these drugs
are now widely available in generic form.
Non-specific, longer-term pharmaceuticals, including anti-depressant
medications (e.g., SRRIs) have some clinical benefits for anxiety, but appear
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Pondera Anxiety Disorder patent (U.S. Patent No. 8,741,319, June 3, 2013)
R. C. Kessler, P. A. Berglund, O. Demler, R. Jin, and E. E. Walters, “Lifetime prevalence and
age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication
(NCS-R),” Archives of Psychiatry, Vol. 62, No. 6, 2005, pp. 593-602.
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A. N. Vgontzas and E. O. Bixler, “Benzodiazepine side effects: role of pharmacokinetics and
pharmacodynamics,” Pharmacology, Vol. 51, 1995, pp. 205-223.
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to be inconsistent and, at times, anxiogenic with other side effects including
sexual dysfunction, sleepiness, and weight gain.4 Finally, while
psychotherapy, especially cognitive behavioral therapy (CBT), has been
shown to reduce anxiety symptoms,5 it is often insufficient to resolve more
serious anxiety disorders and requires specialized services not accessible or
attractive to many people.
Pondera Pharmaceuticals has found the solution to this pressing clinical
problem, which plagues millions every day. Our neuroscientists have
devoted the past three decades to researching the endogenous opioid system
and have discovered a safe and effective method to reduce the emotional and
physical distress signals of the brain. Moreover, we have translated this
groundbreaking research into a unique pharmaceutical formulation, which
combines ultra-low doses of two drugs used extensively in clinical practice
for other indications. By combining ultra-low-doses of roflumilast and
naltrexone, InViva™ provides a safe and effective long-term treatment for
chronic anxiety disorders and related neuropsychiatric conditions.
There is a clear clinical need for InViva™ , a safe and effective anxiolytic
medication for the relief of suffering for millions of anxiety patients, which
targets the underlying neuro-biochemical imbalances responsible for
emotional and physical distress. Since InViva™ relieves chronic anxiety
and related neuropsychiatric symptoms without the serious side effects
experienced with current drugs, this next generation anxiolytic medication
could well become the standard of treatment for these conditions.
PARTNERSHIP AND LICENSING AGREEMENTS: Pondera Pharmaceuticals is seeking
partnership and licensing agreements for our drug development program. Pondera is the sole
owner of these patents and has no obligation to, or contracts with, any third parties with regard to
these patents. For more information, please contact
William E. Crain, President and CEO
Pondera Pharmaceuticals, Inc.
Pondera Biotechnologies, Inc.
www.ponderapharma.com
209 Chadsey Road
Pownal ME 04069
(207) 688-4494
[email protected]
E. Cascade, A. H. Kalali and S. H. Kennedy, “Real-world data on SSRI antidepressant side
effects,” Psychiatry (Edgmont), Vol. 6, Vol. 2, 2009, pp. 16-18.
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R. E. Stewart and D. L. Chambless, “Behavioral therapy for adult anxiety disorders in clinical
practice: a meta-analysis of effectiveness studies,” Journal of Consulting and Clinical
Psychology, Vol. 77, No. 4, 2009, pp. 595-606.
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