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Pain Therapeutics Inc. Message Board

boorsrus 7 posts  |  Last Activity: Jul 25, 2014 1:52 PM Member since: Sep 20, 2004
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  • Reply to

    New abuse oxy approved

    by sellifibuy Jul 23, 2014 5:48 PM
    boorsrus boorsrus Jul 25, 2014 1:52 PM Flag

    From the L.A.Times 7/23/14:

    The U.S. Food and Drug Administration approved a new form of the powerful and controversial pain reliever OxyContin that is designed to be more resistant to abuse, but experts warned the drug could wind up having the opposite effect.
    Purdue Pharma’s Targiniq ER combines a long-acting form of the opioid analgesic oxycodone with the medication naloxone, which is commonly used to reverse the effects of an opioid overdose.
    In Targiniq, the naloxone is included not to reverse an overdose but to block the euphoric effects of oxycodone and thus make it less enticing to many addicts.

    However, the naxolone doesn’t kick in when the pills are swallowed whole. Most people who abuse oxycodone take the pills this way, according to the FDA.The new drug, approved Wednesday, can be crushed and then snorted or injected to release its full narcotic payload instantly — the pattern of abuse that fueled addiction and overdoses involving Purdue’s original OxyContin pills. The naxolone becomes active when the pills are crushed.
    Targiniq was expected to “deter, but not totally prevent,” abuse, the FDA said in its statement announcing the drug’s approval.

    8
    Sharon Hertz, deputy director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, said the move was part of an agency strategy to meet the needs of pain sufferers while deterring addiction and overdose.
    “The FDA is committed to combating the misuse and abuse of all opioids,” Hertz said in a statement. “The development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.”
    But Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said the FDA’s approval of Targiniq could “exacerbate this crisis.”
    New painkiller approved by FDA
    2
    A spokesman for Purdue declined to comment on Kolodny’s concerns. In a statement, Chief Executive Mark Timney lauded the company’s efforts to develop drugs that provide pain relief and help “deter misuse and abuse.”
    Prescription pain relievers such as OxyContin are involved in more than 16,000 fatal overdoses annually, and the U.S. Centers for Disease Control and Prevention declared the steep rise in such deaths over the last decade an epidemic.
    OxyContin releases up to 80 milligrams of oxycodone over 12 hours. As with other forms of oxycodone, taking too much Targiniq via any method can cause an overdose and death.

    The original OxyContin pills were introduced in 1996, but Purdue stopped selling them in 2010 and introduced a new formulation that was more difficult to crush. Until Wednesday, it was the only abuse-deterrent narcotic pain reliever approved by the FDA.
    Lynn Webster, a pain and addiction specialist and former president of the American Academy of Pain Medicine, agreed that abuse-deterrent drugs were no substitute for judicious prescribing.
    But, he said, “the obvious alternative is not to have abuse-deterrent formulations, and I don’t know anyone who would find that preferable.”
    The approval of Targiniq was the second controversial decision by the FDA in recent months. In April, the agency touched off a firestorm of criticism when it gave a San Diego company permission to sell Zohydro, a long-acting, crushable form of hydrocodone, another widely abused narcotic.
    Targiniq was approved to provide relief for pain severe enough to require daily, around-the-clock, long-term opioid treatment when no alternatives are available. The FDA cautioned that it should not be used for as-needed pain relief.
    “Given Targiniq ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management,” the agency said.

  • Reply to

    Pfizer conference call next week

    by carnivalwii Jul 22, 2014 10:32 AM
    boorsrus boorsrus Jul 22, 2014 3:16 PM Flag

    Barbier alluded to this possibility several times in the course of PTIE's Q1 conference call.

  • Reply to

    Connecting the Dots

    by aawilliam2003 Jul 6, 2014 10:42 AM
    boorsrus boorsrus Jul 14, 2014 2:14 PM Flag

    News on yet another experimental approach to refine the diagnostic process for the detection of early-onset Alzheimer's Disease (from the WSJ 7/13/14):

    COPENHAGEN—Efforts to detect Alzheimer's disease earlier and more cheaply are focusing on signs of the ailment in the eye and sense of smell.

    Scientists have found that certain biological changes in the retina and lens of the eye, and in the sense of smell, may help predict whether people with no or minor memory issues may go on to develop the progressive brain disease, according to findings presented here Sunday at the Alzheimer's Association International Conference.

    Alzheimer's disease is diagnosed primarily by clinical examination using memory tests and questions about how a patient is functioning. But researchers are attempting to devise tools, particularly using biological markers, to improve the detection of early stages of the disease, said David Knopman, a neurologist at Mayo Clinic and a member of the Alzheimer's Association Medical and Scientific Advisory Council.

    The disease's pathology in the brain typically begins decades before the appearance of memory symptoms.

    Looking for changes in the eye or smell represent "simpler, less invasive" methods that are more feasible for use in doctor's offices and other clinical settings, Dr. Knopman said.

    Since there aren't yet any treatments that stop the progression of Alzheimer's—and some people may not want to know they face a devastating disease without a cure—earlier detection primarily could be helpful for research purposes in identifying people who are good candidates to participate in prevention trials and to monitor brain changes that occur as the disease progresses.

    Many experimental disease-modifying treatments are under development. Once such a treatment is available, the hope is to identify people at greater risk of Alzheimer's and give them the treatment before they exhibit memory symptoms.

    Currently, brain imaging can be used to detect one major pathology associated with the disease—clumped deposits of the protein amyloid—but it is expensive and used primarily for research, not in doctors' offices.

    Efforts to develop blood-based tests for Alzheimer's generate much excitement among the public but none are ready for prime time yet, experts say.

    But amyloid plaques found in the brain also are known to be deposited in the eye. Two company-funded studies found that those deposits can be detected through noninvasive eye-imaging technology and are highly correlated with the amyloid results from brain imaging.

    Cognoptix Inc., a closely held biotech company in Acton, Mass., focuses on amyloid detection in the lens of the eye. CSIRO Australia, the country's national science agency, and its Sacramento, Calif.-based partner, NeuroVision Imaging LLC, have been studying the retina, in the back of the eyes.

    The retina is like a "piece of brain outside the brain," said Shaun Frost, a researcher at CSIRO Australia.

    The first 40 patients in a 200-participant study showed that retina changes correlated strongly with amyloid plaque development in the brain. The full study will be completed this year, according to Dr. Frost.

    It remains to be seen whether eye imaging will prove better than memory tests at detecting Alzheimer's. There has been limited research to track whether early signals in the eye actually predict development of the disease.

    Smell is another area of interest because the odor center of the brain appears particularly vulnerable to Alzheimer's pathology and the ability to identify different smells becomes impaired relatively early in the disease process.

    A study of some 1,000 individuals without Alzheimer's diagnoses who were examined from 2004 to 2006, using a simple scratch-and-sniff smell test known as the UPSIT, showed that lower scores on the test were associated with a greater risk of developing Alzheimer's—even if the individual was cognitively normal at the beginning of the study, said Davangere Devanand, a Columbia University psychology and psychiatry professor.

    Researchers cautioned that more work is needed and that a number of other factors can influence smell, including smoking and ailments such as Parkinson's and schizophrenia.

  • Reply to

    Connecting the Dots

    by aawilliam2003 Jul 6, 2014 10:42 AM
    boorsrus boorsrus Jul 11, 2014 3:09 PM Flag

    Let's not get carried away here. From the WSJ OnLine dated 7/8/14:

    LONDON—Shares in British biotech group Proteome Sciences PLC rose sharply Tuesday after the company made what it called a "significant step" toward developing a blood test for Alzheimer's.
    In a study co-written with researchers from King's College London, the company said it has identified a set of 10 proteins in blood that can predict the onset of Alzheimer's, the most common form of dementia.
    There is currently no accurate way to predict who will develop Alzheimer's and no long-lasting drug treatments for those affected. Brain-imaging and tests of cerebrospinal fluid can show signs of the disease's progression, but a blood test would be simpler, cheaper and less invasive.
    Proteome shares jumped 17% to $38.50 in London trading.
    The study, published Tuesday in the journal Alzheimer's & Dementia, took blood samples from 1,148 people in three countries, comprising 476 with Alzheimer's, 220 with mild cognitive impairment and 452 elderly patients with no dementia symptoms.
    Researchers said the 10 proteins they have identified can predict with 87% accuracy whether someone with mild cognitive impairment will develop Alzheimer's within a year.
    A number of other companies have been working on blood-protein tests for Alzheimer's in recent years, with varied results. U.K. Secretary of State for Health Jeremy Hunt called the findings of the latest study "welcome research on an issue we have made a national priority."
    Dementia experts welcomed the Proteome study findings but cautioned that they need to be replicated in larger groups of people and that a test for Alzheimer's is likely to be many years away.
    "The results reported today are interesting but as the authors point out there is still a very large amount of work remaining until a usable blood test for Alzheimer's disease becomes available," said Adrian Pini, a senior lecturer at King's College.
    "These 10 proteins can predict conversion to dementia with less than 90% accuracy, meaning one in 10 people would get an incorrect result," said James Pickett, head of research at the Alzheimer's Society. "Therefore, accuracy would need to be improved before it could be a useful diagnostic test."
    Identifying patients likely to develop the disease earlier is one of the priorities of Alzheimer's research.
    This is partly so drug companies can select the right people to participate in clinical trials of experimental drugs in development.
    "Alzheimer's begins to affect the brain many years before patients are diagnosed with the disease. Many of our drug trials fail because by the time patients are given the drugs, the brain has already been too severely affected," said Simon Lovestone, a senior author of the study.
    Developing a treatment for Alzheimer's is one of the big untapped opportunities for drug companies, but progress has been achingly slow over the last decade. A number of high-profile failures in late-stage trials have led many companies to exit the field.
    Merck & Co. and AstraZeneca PLC are working on late-stage trials of experimental Alzheimer's drugs in development, but the latter gives its compound just a 9% chance of success.
    "Since there is as yet no cure for Alzheimer's, learning later that you have the disease is preferable to finding out early. The test needs to be backed up by work on drugs which may halt the progress of the disease," said Doctor Jackson, a professor at Birmingham City University.
    Research into drugs targeting the brain and central nervous system makes up just 15% of the industry's projects, estimates Barclays, despite the disproportionate cost to national health systems.

  • Reply to

    Remoxy- the end game

    by aawilliam2003 Jul 1, 2014 9:43 AM
    boorsrus boorsrus Jul 1, 2014 12:01 PM Flag

    Here's why you might be right, aaw. From WSJ/OnLine 6/18/14:

    Taking a page from the big pharma playbook, Purdue Pharma is eliminating one-third of its research and development apparatus as part of a reorganization that will now emphasize acquiring or licensing medicines that are developed elsewhere.

    As a result of the move, approximately 100 employees will be let go, according to a Purdue spokesman, although he says that the company’s one R&D facility, which is located in Cranbury, N.J., will remain open. The drug maker, which is based in Stamford, Ct., currently employs about 1,700 people, including sales reps scattered around the country.

    “We’re moving the organization from a historical focus on internal innovation toward a more business-oriented model, which is consistent with the overall industry,” the spokesman tells us. He adds that early-stage discovery is being reduced, but that drug development for late-stage products is largely being maintained. He declined to say how much money is being saved.

    The strategic shift comes less than six months after Purdue, which is best known for marketing the controversial OxyContin prescription painkiller, hired Merck veteran Mark Timney as its chief executive and president. At Merck, he was most recentlypresident of global primary care, and headed sales and marketing for managed care accounts.

    In scaling back R&D, Timney is emulating the trend among the largest drug makers which, in recent years, have gradually shed various drug discovery and development efforts in favor of acquiring or licensing compounds from smaller biotechs or, in some cases, universities. Merck is among those that have taken such steps.

    Purdue, however, has never been an R&D powerhouse. The privately held drug maker sells a handful of products besides OxyContin, which generated $2.5 billion in sales last year, according to IMS Health, as well as several over-the-counter medicines. An unspecified amount of resources were devoted recently to developing a tamper-resistant, extended-release version of the hydrocodone painkiller.

    Two months ago, Purdue filed an application with the FDA seeking approval to market the drug, which the company says was designed to make it more difficult for people to crush and then inject or snort the contents.

  • Twelve month closing high today on higher volume. Market confirmation of belief that Pfizer will stay the course with Remoxy? Or the work of all the mindless spammers who are infesting this forum?

  • boorsrus by boorsrus Jun 18, 2014 7:39 PM Flag

    From today's WSJ/OnLine:

    Taking a page from the big pharma playbook, Purdue Pharma is eliminating one-third of its research and development apparatus as part of a reorganization that will now emphasize acquiring or licensing medicines that are developed elsewhere.

    As a result of the move, approximately 100 employees will be let go, according to a Purdue spokesman, although he says that the company’s one R&D facility, which is located in Cranbury, N.J., will remain open. The drug maker, which is based in Stamford, Ct., currently employs about 1,700 people, including sales reps scattered around the country.

    “We’re moving the organization from a historical focus on internal innovation toward a more business-oriented model, which is consistent with the overall industry,” the spokesman tells us. He adds that early-stage discovery is being reduced, but that drug development for late-stage products is largely being maintained. He declined to say how much money is being saved.

    The strategic shift comes less than six months after Purdue, which is best known for marketing the controversial OxyContin prescription painkiller, hired Merck veteran Mark Timney as its chief executive and president. At Merck, he was most recentlypresident of global primary care, and headed sales and marketing for managed care accounts.

    In scaling back R&D, Timney is emulating the trend among the largest drug makers which, in recent years, have gradually shed various drug discovery and development efforts in favor of acquiring or licensing compounds from smaller biotechs or, in some cases, universities. Merck is among those that have taken such steps.

    Purdue, however, has never been an R&D powerhouse. The privately held drug maker sells a handful of products besides OxyContin, which generated $2.5 billion in sales last year, according to IMS Health, as well as several over-the-counter medicines. An unspecified amount of resources were devoted recently to developing a tamper-resistant, extended-release version of the hydrocodone painkiller.

    Two months ago, Purdue filed an application with the FDA seeking approval to market the drug, which the company says was designed to make it more difficult for people to crush and then inject or snort the contents.

PTIE
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