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Pain Therapeutics Successfully Completes Two Multi-dose Safety Studies

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    Pain Therapeutics Successfully Completes Two Multi-dose Safety Studies

    Pain Therapeutics Successfully Completes Two Multi-dose Safety Studies

    Tuesday October 1, 9:45 AM EDT

    SOUTH SAN FRANCISCO, Calif., Oct 1, 2002 /PRNewswire-FirstCall via COMTEX/ -- Pain Therapeutics, Inc. (PTIE), a medical research company, today announced that it has completed two safety studies using multi-doses of OxyTrex(TM) and MorViva(TM), its two lead candidates. The Company believes OxyTrex(TM) and MorViva(TM) could represent a new generation of safer, more efficacious narcotic painkillers.

    "The completion of these two clinical studies marks an important milestone for Pain Therapeutics," said Remi Barbier, president and chief executive officer. "We believe the results of these two studies allow us to continue executing our clinical plan on-time and on-budget. Our next step is to announce the initiation of a large multi-dose safety study with OxyTrex(TM) in the fourth quarter of 2002, followed by the initiation of a pivotal efficacy study in the second quarter of 2003."

    The Company's two clinical studies were randomized, double-blind and designed to assess the occurrence of adverse safety events in patients after multi-dose OxyTrex(TM) or MorViva(TM) treatment was initiated, while tracking patients' analgesic response. As expected, most patients experienced mild to moderate clinical events commonly associated with oxycodone or morphine use, while reporting excellent pain relief.

    OxyTrex(TM) Study

    Forty-nine (49) patients with chronic pain due to severe osteoarthritis were recruited to participate in a clinical study comparing the safety and efficacy of multiple doses of OxyTrex(TM) to oxycodone. Prior to entering the study, all patients stopped taking all pain medications for several days. Immediately following this washout period, 49 patients were assigned to five different treatment groups. Each group received OxyTrex(TM) or immediate release oxycodone either two or four times a day for fourteen (14) days. Safety, pharmacokinetics and efficacy parameters were then assessed at various times during the two week treatment period. The preliminary results of this safety study indicate that no serious health consequences resulted from the use of various dose levels of OxyTrex(TM).

    MorViva(TM) Study

    One hundred sixty (160) patients with post-operative pain participated in a clinical study comparing the safety and efficacy of a continuous intravenous infusion of MorViva(TM) to morphine sulfate. Immediately following major surgery, the study design allowed all patients to receive discretionary amounts of intravenous fentanyl. Several hours after reaching a state of comfort using fentanyl alone, patients were then randomly assigned to four different treatment groups. Each group received a continuous infusion of MorViva(TM) or morphine sulfate over a 48-hour treatment period. In addition to study medication, all patients had concurrent access to intravenous morphine via a patient controlled analgesia (PCA) pump. Safety, pharmacokinetics and efficacy parameters were then assessed at various times during the treatment period. The preliminary results of this safety study indicate that no serious health consequences resulted from the use of three different dose levels of MorViva(TM).

    "The assessment of a novel drug's safety plays a key role in our drug development programs," said Nadav Friedmann, PhD, MD, Pain Therapeutics' chief operating officer. "Based on the results of these two safety studies, combined with our animal data and previously announced clinical data, we continue to believe OxyTrex(TM) and MorViva(TM) could represent important new treatment paradigms for patients with pain."

    As previously announced, Pain Therapeutics has approximately $58 million of cash and cash equivalents as of June 30, 2002 and expects its net cash burn for 2002 to be under $20 million.

    About Opioid Drugs

    Opioid drugs (sometimes called 'narcotic painkillers') are derived from the opium poppy plant. These drugs are widely used throughout the world to treat severe forms of clinical pain. In the United States, for example, opioid drugs represent a $3 billion market and account for over five percent of all drug prescription sales. Despite widespread use, opioid drugs have debilitating side-effects that limit their usefulness at all doses. In addition, chronic use may lead to tolerance, dependence, abuse, or, more rarely, addiction. As a result, some patients prefer to suffer through pain rather than endure the ill effects of opioid drugs. The under-treatment of pain is a serious and growing problem in the U.S. For example, according to the National Institutes of Health, over 40 million Americans are unable to find relief from their pain.

    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, MorViva(TM) and OxyTrex(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. The target market for our drugs exceeds $3 billion in the United States. 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.
    Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 and it is Pain Therapeutics' intent that such statements be protected by the safe harbor created thereby. Examples of such statements include, but are not limited to, any statements relating to our expected cash burn rate for 2002, the anticipated results of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates, the expected commencement of pivotal trials 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 delays in enrolling and completing safety or pivotal trials, unanticipated 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, including its Form 10-K for the year ended December 31, 2001. The BUTTERFLY DESIGN/LOGO is a registered trademark of Pain Therapeutics, Inc.