ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Tea drinkers have lower glaucoma risk

Why Is Chlorella Considered a Superfood?

Soy, cruciferous vegetables could help lower breast cancer treatment side effects

The Long-Term Benefits of Drinking Oolong Tea

Wonderful White Tea: A Drink Fit for an Emperor

Why You Should Try This Sweet-Smelling and Health-Boosting Essential Oil

Arnica: This Powerful Herb Promotes Various Kinds of Healing

Chamomile Tea: Why This Ancient Therapeutic Drink Still Stands Out Today

Get ‘Hooked’ on Cat’s Claw: The Many Benefits of This Amazonian Herb

Try Apple Cider Vinegar and Black Cumin Oil as Your Go-To Salad Dressing

Print Page
Email Article

Pain Therapeutics Announces New Pilot Program For Treating Irritable Bowel Syndrome: Chronic Fatigue Syndrome & Fibromyalgia News

  [ 75 votes ]   [ Discuss This Article ] • November 4, 2002

SOUTH SAN FRANCISCO, Calif., Oct. 30 /PRNewswire-FirstCall/ --
Pain Therapeutics, Inc., (Nasdaq: PTIE), a medical research company, today
announced a pilot program directed at the treatment of irritable bowel
syndrome (IBS) with low-dose opioid antagonist. IBS is a common, chronic
disorder characterized by recurrent, unexplained abdominal pain. Each year,
up to 30 million Americans, mostly women, suffer from symptomatic pain
associated with IBS.

"There are no unrestricted prescription drugs on the market today to treat
patients with IBS," said Remi Barbier, president and chief executive officer
of Pain Therapeutics. "This pilot program offers hope to millions of
Americans who suffer from symptomatic pain associated with IBS and marks a
milestone in broadening the clinical use of the Company's technology."

Pain Therapeutics' new IBS program consists of an Investigational New Drug
(IND) application, plans to initiate a pilot clinical study and further
research into the pharmacology and mechanism of action of low-dose opioid
antagonist therapy for IBS patients. Two issued U.S. patents protect the
Company's rights specifically toward methods of treating IBS patients with
opioid antagonists.

"IBS has traditionally been viewed as an abnormality in gastrointestinal
motility, but it is becoming increasingly clear that IBS patients may also be
suffering from neuronal dysfunction," said Nadav Friedmann, Ph.D., M.D., Pain
Therapeutics' chief operating officer. "We believe the use of specific,
non-toxic low-dose opioid antagonist could elicit broad clinical interest as
the neurology of IBS becomes more widely understood."

Pilot Study, December 2002

Pain Therapeutics has filed an IND application with the FDA to study the
use of low-dose opioid antagonist in IBS patients. As a next step, the
Company plans to conduct a pilot study in a large medical center in Israel.
This pilot study is aimed at validating the biological significance and the
safety of using low-dose opioid antagonist drug therapy in 50 patients
diagnosed with IBS. The Company expects to announce the initiation of this
pilot study in December 2002 and to complete patient enrollment in the second
quarter of 2003. If successful, the results of this study may allow the
Company to enter into a major drug development program aimed at product
approval. The cost to complete this pilot study is expected to be
approximately $150,000.

Results of Independent Study

An independent clinical investigator at the Albert Einstein College of
Medicine evaluated the use of low-dose opioid antagonists in IBS patients. In
an open label study, 21 patients with IBS diagnosed by the Rome II criteria
received a single bedtime dose of low-dose opioid antagonist for six weeks.
Seventeen (17) of 21 patients reported an average reduction of 82 percent in
pain and all gastrointestinal indices of IBS as measured by visual analog
scales of pain and other symptoms. IBS related pain returned to responders in
14 to 45 days after termination of treatment. Each responder was subsequently
allowed to re-initiate therapy with low-dose opioid antagonist, and each again
demonstrated a positive response. Since then, some of the clinical
investigator's patients have remained on low-dose opioid antagonist therapy
for over two years.

Exclusive Rights to Issued Patents

Pain Therapeutics holds exclusive, worldwide commercial rights in a family
of patents and applications directed to the long-term treatment of IBS
patients with opioid antagonists, including issued U.S. Patent No. 6,194,382
and No. 6,395,705. The Company's patent portfolio now includes eight issued
U.S. patents that cover both composition of matter and use claims.

Novel Mechanism of Action

As with most disorders of central nervous system, the etiology of IBS
remains speculative. Academic research suggests that IBS represents an
abnormality of the intestinal opioid system. Opioid receptor cells that line
the intestinal wall normally present a balance of inhibitory and excitatory
responses to the presence of endogenous opioid agonists. In IBS patients,
this cellular balance may be degraded. In such cases, excitatory signals
predominate over inhibitory signals. Hyper-excitatory signaling in the gut
produces intense intestinal pain and other abdominal conditions commonly seen
in IBS patients. According to this putative mechanism of action, treating IBS
patients with low-dose opioid antagonists may block excessive excitatory
signals, thus alleviating the abdominal pain experienced by IBS patients.

About Irritable Bowel Syndrome (IBS)

IBS is a chronic, painful disorder of the intestines that leads to major
changes in bowel habits. IBS causes some patients to have constipation,
diarrhea, or in some cases both. The cause of IBS is not known, and as yet
there is no cure. People with chronic IBS may be unable to attend social
events, hold a job, or travel away from home. Over 10 percent of the U.S.
population suffers from IBS. For unknown reasons, IBS predominantly affects

About Pain Therapeutics, Inc.

We are a medical research company specializing in the discovery and
development of novel proprietary painkillers. We believe our lead drug
candidates, OxyTrex(TM) and MorViva(TM), may offer more pain relief (with no
increase in side-effects) and lower tolerance/dependence, withdrawal effects
or addiction potential compared to conventional forms of oxycodone and
morphine. Our proprietary painkillers are currently in various phases of
clinical testing, including Phase II trials. Pain Therapeutics is traded on
Nasdaq under the symbol PTIE.

Post a Comment

Featured Products From the ProHealth Store
Mitochondria Ignite™ with NT Factor® Ultra EPA  - Fish Oil Ultra ATP+, Double Strength

Article Comments

Be the first to comment on this article!

Post a Comment

Optimized Curcumin Longvida with Omega-3

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get Energized with Malic Acid & Magnesium
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

Fighting Fatigue with Ground-breaking French Oak Wood Extract Fighting Fatigue with Ground-breaking French Oak Wood Extract
Soothe, Heal and Regulate Your Digestive System with Nutrient-Rich Aloe Vera Soothe, Heal and Regulate Your Digestive System with Nutrient-Rich Aloe Vera
The Guaifenesin Story: A centuries-old bark extract used for clearing the airways – now key to a popular FM symptom-reversal protocol The Guaifenesin Story: A centuries-old bark extract used for clearing the airways – now key to a popular FM symptom-reversal protocol
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
Restore Youthful Cognition and Well-Being Restore Youthful Cognition and Well-Being

ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2018 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map