New Medicines

Abuse-resistant OxyContin faces hurdles Durect is developing abuse-resistant OxyContin amid legal headwinds; patches deploying painkillers can last for days.

From what I read this drug is supposed to create pain relief and cause tolerance. What do you think?

http://www.medicalnewstoday.com/medicalnews.php?newsid=58973&nfid=crss

Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced the initiation of a Phase III study with Oxytrex, an investigational drug. Oxytrex is a unique oral painkiller for patients who suffer from persistent severe chronic pain. The Company believes Oxytrex offers less physical dependence/withdrawal than oxycodone, an 80-year-old prescription painkiller still widely used today to treat persistent severe chronic pain.

"We remain encouraged by the strong science around Oxytrex published in several top journals, including a recent article in Journal of Neurobiology that further elucidates the unique attributes of ultra-low-dose opioid antagonists," said Remi Barbier, president and chief executive officer.

This study is being referred to as the "Extreme Study" in deference to patients who depend on extremely high daily doses of oxycodone (greater than or equal to 120 mg per day) to treat severe chronic pain. The Company believes this sub-population of patients is prone to physical dependence/withdrawal.

In the second half of 2007, Pain Therapeutics plans to initiate a large study with Oxytrex in a broad patient population.

"Extreme Study" Design

This clinical study is randomized, double-blinded, multi-center and placebo-controlled. The study will enroll approximately 120 patients who have each been taking greater than or equal to 120 mg of oxycodone per patient per day for over a year. Patients who meet this and all other eligibility requirements are randomized to receive twice-daily doses of 100 nanograms (i.e., 0.0001 mg) ultra-low-dose naltrexone or matching placebo for two weeks. At the conclusion of the treatment period, patients check into a clinic and receive an injection of a high-dose opioid antagonist to precipitate withdrawal. During the withdrawal phase of the study, patients are closely monitored and measured for signs and symptoms of physical dependence/withdrawal using the Subjective Opiate Withdrawal Scale. The study's primary endpoint is prospectively defined as physical dependence/withdrawal scores in the treated arm compared to placebo. For ethical and other reasons, the study protocol allows an interim analysis.

About Oxytrex

Pain Therapeutics owns commercial rights to Oxytrex, a unique oral painkiller that preferentially inhibits an excitatory effect of opioid receptors. This excitatory effect is believed to counteract analgesia (pain relief) and cause tolerance. Its inhibition enhances pain relief and minimizes opioid tolerance. The FDA has not yet evaluated the merits, safety or efficacy of Oxytrex.

About Pain Therapeutics, Inc.

Pain Therapeutics is a biopharmaceutical company that develops novel drugs for pain management and oncology. We have three investigational drug candidates in clinical programs. Remoxy(TM) and PTI-202 are proprietary, abuse-resistant forms of opioid drugs. Oxytrex is a novel, next-generation painkiller that potentially offers less physical dependence than currently marketed opioid painkillers. We are also developing a novel radio-labeled monoclonal antibody to treat metastatic melanoma, a rare but deadly form of skin cancer. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please consult our website: http://www.paintrials.com/.

Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.

Pain Therapeutics, Inc.
http://www.paintrials.com/

First-Time Generic Approvals - December 2006

Tablets/Capsules Only

Updated 02-10-07 to include Teva imprints

Hey Everyone  I ran across this article and I immediately thought  I should post it.

Take care

Discovery Could Lead to New Pain Drugs, Scientists Say By Miranda Hitti
WebMD Medical News Reviewed By Brunilda Nazario, MD
on Wednesday, December 13, 2006

Dec. 13, 2006 -- Scientists have discovered rare gene mutations that may block pain.
The mutations, found in the SCN9A gene, were spotted in six children in Pakistan who reportedly had never felt pain.
The discovery may lead to development of new pain drugs, write the researchers, who include C. Geoffrey Woods, MD, of England's University of Cambridge.
Their study is published in Dec. 14 issue of the journal Nature.
Since pain alerts people to the fact that they're hurt, having no sense of it can be dangerous.
For instance, if you couldn't feel pain, you might not yank your hand off a hot object, notes a journal editorial.
But pain can also be overwhelming, and scientists are always looking for new ways to safely tame the sensation.
Pain Blocked
The six children in Woods' study had reportedly been completely insensitive to physical pain since birth.
The kids came from three related families in northern Pakistan and ranged in age from 6 to 12. They had normal intelligence and showed no sign of nerve damage. Their other senses worked well; they could feel heat, cold, and touch.
One of the kids studied, a 10-year-old boy, regularly performed in "street theatre," the researchers write.
"He placed knives through his arms and walked on burning coals, but experienced no pain," Woods team notes. The boy died before turning 14 after jumping off the roof of a house.
The other children had frequent bruises and cuts. Most had broken bones at some point.
There were reports in the last century of other people who didn't feel pain, say Woods and colleagues, but they are "very rare," with "only a handful of such patients."
Gene Mutation
The researchers screened the DNA of the affected children -- except for the boy who had died after jumping off the roof, since his DNA wasn't available.
The DNA tests showed that the children had mutations in their SCN9A gene.
That gene makes a protein involved in sending pain messages (the sensation of pain) to nerves.
These gene mutations may have blocked the children from feeling pain, Woods' team notes.
If so, scientists may be able to make new pain relieving drugs that target the protein made by the SCN9A gene, the researchers write.
If the gene discovery bears fruit, "it might be possible to develop a new generation of drugs that can effectively mute the megaphone of pain," writes editorialist Stephen Waxman, MD, PhD, in Nature.
Waxman works in the neurology department at Yale University's medical school.
SOURCES: Cox, J. Nature, Dec. 14, 2006; vol 444: pp 894-898. Waxman, S. Nature, Dec. 14, 2006; vol 444: pp 831-832. News release, University of Cambridge.

First-Time Generic Approvals - November 2006

Tablets/Capsules Only

First-Time Generic Approval - October 2006

Tablets/Capsules Only

Natural-born painkiller found in human saliva

22:00 13 November 2006 -- NewScientist.com news service -- Andy Coghlan

...Saliva from humans has yielded a natural painkiller up to six times more powerful than morphine, researchers say.
The substance, dubbed opiorphin, may spawn a new generation of natural painkillers that relieve pain as well as morphine but without the addictive and psychological side effects of the traditional drug.
When the researchers injected a pain-inducing chemical into rats’ paws, 1 gram of opiorphin per kilogram of body weight achieved the same painkilling effect as 3 grams of morphine.
The substance was so successful at blocking pain that, in a test involving a platform of upended pins, the rats needed six times as much morphine as opiorphin to render them oblivious to the pain of standing on the needle points...

NewScientist.com news service

On October 25, 2006 the Food and Drug Administration approved Tyzeka (telbivudine), manufactured by Novartis, for treatment of chronic hepatitis B.

Tyzeka, a tablet taken once daily, suppresses the hepatitis B virus. Tyzeka is not a cure but is indicated for long-term management of the infection.

The FDA estimates that 70,000 Americans become infected with hepatitis B every year. The virus is blood borne and spreads by sexual contact or blood contamination. The virus causes lifelong infection and serious liver damage. Ultimately liver cancer or liver failure may result.

Tyzeka will be distributed by Idenix Pharmaceuticals of Cambridge, Massachusetts.

Pill Identification - Tyzeka

600 mg: White to slightly yellowish film-coated oval tablets imprinted with LDT on one side

For more information, please see the Novartis press release.

Patient Information - TYZEKA