Advancing Therapeutic Development for Pain and Opioid Use Disorders Through Public-Private Partnerships Proceedings of a Workshop (2018) / Chapter Skim
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5 Therapeutic Development for Opioid Use Disorders and Overdose Prevention and Reversal
5 Therapeutic Development for Opioid Use Disorders and Overdose Prevention and Reversal
Pages 45-54
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From page 45... ...
. • Challenges in designing trials for opioid use disorder treatments include the difficulty of establishing reasonable inclusion and ex clusion criteria, the decision whether to use a placebo control or active comparator, and the selection of meaningful outcome measures (Walsh)
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From page 46... ...
. • Through a public–private partnership between the National Insti tute on Drug Abuse and private-sector partners, a nasal spray for mulation of naloxone called NARCAN®, which is used to reverse overdose, was developed and received FDA approval quickly (Crystal)
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From page 47... ...
Opioid use disorder is a chronic relapsing brain disease that is expressed as compulsive behavior and that is accompanied by robust physical dependence, said Sharon Walsh. The diagnostic criteria for a substance use disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
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From page 48... ...
SOURCES: Presented by Sharon Walsh, October 11, 2017; APA, 2013. Buprenorphine, a high-affinity μ-opioid receptor partial agonist, received FDA approval as a sublingual tablet, either alone or in combination with naloxone, for the treatment of opioid addiction in 2002.1 It works through several different mechanisms to suppress opioid withdrawal symptoms, reduce craving, and produce opioid blockade, said Walsh.
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From page 49... ...
One such drug is lofexidine, an α-adrenergic agonist, which is being developed for the treatment of withdrawal symptoms by a small company called World Meds, with substantial support from NIDA. In a recent Phase III trial of this medication conducted by Walsh and colleagues, lofexidine was shown to significantly suppress the symptoms of opioid withdrawal (compared with placebo)
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From page 50... ...
data suggested that 300 mg of RBP-6000 in subjects with opioid use disorder would translate into plasma concentrations of buprenorphine ≥ 2 ng/mL and 75 to 92 percent occupancy of the µ-opioid receptors in the brain. This led to a Phase III 24-week multicenter trial in treatment-seeking patients who met the DSM-5 criteria for moderate or severe opioid use disorder, followed by an open-label safety extension study.
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From page 51... ...
Among the inclusion and exclusion criteria that will need to be carefully considered are poly-substance abuse, liver function, venous access, and co-morbid mental health disorders and infectious diseases such as hepatitis C and HIV, which are common in this population, she said. Other important considerations include the possibility of deception when using self-report measures; preparing for adverse events, including unplanned pregnancies, overdose, and seroconversion (time period in which HIV antibodies become detectable)
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From page 52... ...
, which requires drug developers to take into account state laws regarding reporting and other issues related to confidentiality. THERAPEUTIC DEVELOPMENT TO REVERSE OVERDOSE Naloxone has been around for a long time to address the immediate emergency issue of treating opioid overdose, said Roger Crystal.
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From page 53... ...
OPIOID USE DISORDERS AND OVERDOSE PREVENTION AND REVERSAL 53 device can be used in all directions and does not need priming, easing delivery even in a crisis situation.
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