<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265775730291"
                     
      &lt;p&gt;SAN ANTONIO  --  A personalized, online self-management program helped patients with pain syndromes improve coping skills and reduce stress and depression in two studies reported here.&lt;/p&gt;
&lt;p&gt;Patients randomized to the self-management program demonstrated significant improvement in multiple social, emotional, and behavioral outcomes after six months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01). Improvement in some parameters occurred within one month. A control group that was not exposed to the program showed no significant improvement.&lt;/p&gt;
&lt;p&gt;&quot;Our goal is to help people communicate better with providers, understand better how they can use social support, understand the comorbid conditions, like anxiety and depression, and develop cognitive skills to help get them through their pain episodes,&quot; said Emil Chiauzzi, PhD, of Inflexxion, the Newton, Mass. company that developed the program.&lt;/p&gt;
&lt;p&gt;Although the studies involved patients with migraine or low-back pain, programs are being developed for other types of pain condition, including several forms of neuropathic pain.&lt;/p&gt;
&lt;p&gt;The online program, demonstrated at &lt;a href=&quot;http://www.painACTION.com&quot; mce_href=&quot;http://www.painACTION.com&quot; target=&quot;_blank&quot;&gt;www.painACTION.com&lt;/a&gt;, employs patient-specific information to generate individualized self-management strategies.&lt;/p&gt;
&lt;p&gt;Patient responses to assessments are analyzed by a &quot;recommendation engine,&quot; which produces content recommendations designed to address each patient&apos;s informational and self-management needs.&lt;/p&gt;
&lt;p&gt;Elements on the Web site include multimedia education units, a pain inventory, interactive tools that provide information based on patient-provider communication, and medication risk management.&lt;/p&gt;
&lt;p&gt;&quot;The content on the Web site is focused on teaching people practical skills to manage the behavioral side of pain,&quot; Jonas Bromberg, PsyD, also of Inflexxion, said in an interview.&lt;/p&gt;
&lt;p&gt;Bromberg presented results of a randomized study involving 210 patients, all of whom met International Headache Society diagnostic criteria for migraine, with or without aura.&lt;/p&gt;
&lt;p&gt;Patients assigned to the online program completed at least eight 30-minute session during the first month of the study and at least five more 30-minute sessions during the five-month follow-up period. Patients in the control group continued to receive usual care without exposure to the Web site.&lt;/p&gt;
&lt;p&gt;Participants assigned to the online program had a minimum set of requirements for each session, which were provided at log-in. Follow-up assessments occurred at one, three, and six months.&lt;/p&gt;
&lt;p&gt;The two groups were balanced with respect to sex and headache frequency and severity, the researchers said.&lt;/p&gt;
&lt;p&gt;Bromberg reported that patients assigned to the self-management program demonstrated significant improvement in: &lt;ul&gt; &lt;li&gt;Headache self-efficacy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 compared with baseline)&lt;/li&gt; &lt;li&gt;Use of relaxation (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Use of social support (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Pain catastrophizing (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Depression (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Chiauzzi presented results from a randomized study of 209 patients with low-back pain. The design was similar to that of the migraine study, except results were analyzed for between-group differences.&lt;/p&gt;
&lt;p&gt;The results showed significant improvement in the study group versus control group with respect to: &lt;ul&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Coping (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Social supports (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The data showed significant effects of both treatment (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) and time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) favoring the Web site versus control. Chiauzzi said patients assigned to the Web site had greater mean improvement at posttest, three months, and six months.&lt;/p&gt;
&lt;p&gt;Qualitative analysis suggested that Web site participants had clinically meaningful improvement in depression, anxiety, and stress.&lt;/p&gt;
&lt;p&gt;Additionally, patients in the self-management program reported a 12.3% decrease in pain from baseline, versus 7% in the control group.&lt;/p&gt;
&lt;p&gt;Access to the Web site did not improve physical functioning.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The studies were funded by the National Institutes of Health.&lt;/p&gt;&lt;p&gt;Chiauzzi and Bromberg are employees of Inflexxion, developer of the online program.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_434"
                     title="AAPM: Capsaicin Patch Unaffected by Anesthestics (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18351?impressionId=1265775730291"
                     
      &lt;p&gt;SAN ANTONIO  --  The analgesic properties of a capsaicin patch (NGX-4010, Qutenza) remained intact when used in combination with three different topical anesthetics to reduce initial skin discomfort, researchers reported here.&lt;/p&gt;
&lt;p&gt;Pain reduction among patients with neuropathic pain conditions averaged about 30% during weeks two through 12 compared with baseline levels and did not differ by the the type of lidocaine-based pretreatment.&lt;/p&gt;
&lt;p&gt;Between 45% and 50% of patients in each group had at least a 30% decrease in pain.&lt;/p&gt;
&lt;p&gt;&quot;No significant differences in tolerability were noted among the three topical anesthetics evaluated,&quot; Lynn R. Webster, MD, of Lifetree Clinical Research in Salt Lake City, and colleagues concluded in a poster presentation at the American Academy of Pain Medicine meeting.&lt;/p&gt;
&lt;p&gt;&quot;Preliminary efficacy of NGX-4010 was similar, irrespective of the topical anesthetic and comparable to results in previous phase III studies using NGX-4010 in patients with postherpetic neuralgia.&quot;&lt;/p&gt;
&lt;p&gt;The 8% capsaicin patch has FDA approval for management of postherpetic neuralgia. Prior to applying the patch, the skin is treated with a topical anesthetic to reduce discomfort. In previous studies of NGX-4010, a 4% lidocaine cream (LMX4) had been applied prior to the patch.&lt;/p&gt;
&lt;p&gt;Whether the type of anesthetic pretreatment affected the safety and efficacy of NGX-4010 was unclear. To address the issue, investigators conducted a randomized, multicenter, open-label clinical study involving 117 patients with moderate-to-severe postherpetic neuralgia, HIV-distal sensor polyneuropathy, or peripheral diabetic neuropathy.&lt;/p&gt;
&lt;p&gt;The patients were randomized to a 60-minute pretreatment period with one of three 4% lidocaine-based topical anesthetics (LMX4, Topicaine, or Betacaine). Within each anesthetic group, patients were further randomized to a 60- or 90-minute application of NGX-4010.&lt;/p&gt;
&lt;p&gt;Safety and tolerability assessments included adverse events, skin assessments by a 7-point scoring system, pain score on the day of treatment, and use of medication for treatment-related discomfort.&lt;/p&gt;
&lt;p&gt;The principal efficacy outcome was the percentage change in mean pain scores (reflecting average pain for the past 24 hours) from baseline to weeks two through 12.&lt;/p&gt;
&lt;p&gt;Men accounted for about 60% of the study population, and three-fourths of the patients had peripheral diabetic neuropathy. Duration of pain averaged four to five years. The baseline pain level averaged 5 to 6 (moderate) on the 0-10 pain scale.&lt;/p&gt;
&lt;p&gt;In all three groups, the pain level increased slightly or not at all, following application of the capsaicin patch. In general, patients treated for 90 minutes reported more pain than those treated for 60 minutes, but the difference was not statistically significant.&lt;/p&gt;
&lt;p&gt;Within the first 48 hours, 70% to 75% of patients in each group reported &amp;#8805;33% increase in pain.&lt;/p&gt;
&lt;p&gt;More than half the patients in each group required oral analgesics for treatment-related pain, and patients treated for 90 minutes with transdermal capsaicin were more likely to require oral analgesics than were the patients who were treated for 60 minutes.&lt;/p&gt;
&lt;p&gt;The most common adverse event in all three groups was mild to moderate burning or pain at the application site.&lt;/p&gt;
&lt;p&gt;From weeks two through 12, the average pain reduction compared with baseline ranged from 27.2% to 34.3% and did not differ significantly among the groups. About half the patients had at least a 30% reduction in pain compared with baseline.&lt;/p&gt;
&lt;p&gt;At week 12, 35% to 42% of patients in each group reported that their pain was &quot;much improved,&quot; and about 60% to 70% said their pain was &quot;improved.&quot;&lt;/p&gt;
&lt;p&gt;None of the between-group differences was statistically significant.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by NeurogesX.&lt;/p&gt;&lt;p&gt;Webster&apos;s disclosures include Ameritox, Cephalon, King Pharmaceuticals, Medtronic, Arcion Therapeutics, Advanced Bionics, CoMentis, F. Hoffman-La Roche, Forest Laboratories, Hisamitsu Pharmaceuticals, Merck, Myriad Pharmaceuticals, Nektar Therapeutics, NeurogesX, Pfizer, Wyeth, XenoPort, Nervo, Neuromed Pharmaceuticals, and Purdue Pharma.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_426"
                     title="AAPM: Spine Stimulation Leads to Durable Pain Relief (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18344?impressionId=1265775730291"
                     
      &lt;p&gt;SAN ANTONIO  --  Spinal cord stimulation provided durable pain relief for patients with complex regional pain syndrome (CRPS) but did not halt progression, a retrospective analysis of a small clinical series showed.&lt;/p&gt;
&lt;p&gt;During follow-up for as long as 20 years, patients continued to rate their pain as significantly below baseline levels. Improvements in depression, medication use, and quality of life also proved durable.&lt;/p&gt;
&lt;p&gt;However, the pain syndrome progressed to other areas in all patients.&lt;/p&gt;
&lt;p&gt;&quot;All patients in this series experienced a gradual enlargement in the area affected over time,&quot; Krishna Kumar, MB, BS, of Regina Qu&apos;appelle Health Region in Regina, Saskatchewan, said at the American Academy of Pain Medicine meeting. &quot;Stimulation does not appear to retard disease spread.&quot;&lt;/p&gt;
&lt;p&gt;Nonetheless, 22 of the 25 patients in the series said they were satisfied with their pain relief and would have the procedure again.&lt;/p&gt;
&lt;p&gt;In a separate presentation at the meeting, Kumar reported that spinal cord stimulation led to significantly better outcomes than medical management in patients with failed back surgery syndrome.&lt;/p&gt;
&lt;p&gt;CRPS has an undetermined etiology, and there&apos;s no cure. The condition responds poorly to conventional medical therapy and to interventions such as transcutaneous electrical nerve stimulation, chemical blocks, sympathectomy, and physical therapy, said Kumar.&lt;/p&gt;
&lt;p&gt;Several studies and meta-analyses have shown that spinal cord stimulation relieves pain and other symptoms of CRPS during short- and mid-term follow-up. Whether the benefits persisted over the long term was unclear, Kumar continued.&lt;/p&gt;
&lt;p&gt;To assess long-term outcomes after spinal cord stimulation, Kumar and colleagues examined records of 196 patients who underwent spinal cord stimulation procedures. They identified 25 patients who met International Association for the Study of Pain criteria for CRPS and who agreed to participate.&lt;/p&gt;
&lt;p&gt;The cohort had a median follow-up of 63 months, a mean of 88 months, and a range of 18 to 235 months. The group comprised 13 men and 12 women whose mean age was 51 and whose ages ranged from 32 to 91. Ten of the 25 had upper-extremity pain and 15 had lower-extremity pain. In all cases the pain had not responded to conventional medical therapy.&lt;/p&gt;
&lt;p&gt;Assessment of each patient included pain rating by a visual analog scale (VAS), an index of physical functioning, a depression scale, a general health status survey, and a quality-of-life survey. Patients were assessed at implantation, three months and one year after implantation, and at last follow-up.&lt;/p&gt;
&lt;p&gt;All categories of medication use remained below baseline levels at last follow-up, including antidepressants, anticonvulsants, anti-inflammatory drugs, and narcotic drugs.&lt;/p&gt;
&lt;p&gt;Average scores on all of the survey instruments improved significantly from implantation to three months (&lt;em&gt;P&lt;/em&gt;=0.002 to &lt;em&gt;P&lt;/em&gt;=0.000). One-year results showed some reversal of the improvement, but scores for all outcomes remained below baseline levels.&lt;/p&gt;
&lt;p&gt;At last follow-up, mean scores remained significantly improved over baseline values (&lt;em&gt;P&lt;/em&gt;=0.003 to &lt;em&gt;P&lt;/em&gt;=0.001).&lt;/p&gt;
&lt;p&gt;The greatest improvement in health status and pain scores occurred in patients who were 40 or younger, who had stage I CRPS, and who underwent spinal cord stimulation within a year of diagnosis, said Kumar.&lt;/p&gt;
&lt;p&gt;&quot;Spinal cord stimulation is equally effective for men and women and for upper- and lower-limb CRPS,&quot; he said. &quot;Early institution is necessary to secure optimal patient outcomes, as delay exceeding one year appears to limit the effectiveness of the intervention.&quot;&lt;/p&gt;
&lt;p&gt;&quot;On the basis of these results, we conclude that spinal cord stimulation is an effective long-term management modality for CRPS and should be considered earlier in the treatment continuum, preferably within the first year of symptom onset,&quot; Kumar added.&lt;/p&gt;
&lt;p&gt;In a separate poster presentation, Kumar reported findings from a study of 100 patients with failed back surgery syndrome who were treated at 12 centers worldwide. Half the patients received conventional medical management and half had medical management plus spinal cord stimulation. The primary outcome was pain at six and 24 months after treatment.&lt;/p&gt;
&lt;p&gt;At six months, 48% of patients with spinal cord stimulation had at least 50% improvement in leg pain, compared with 9% of patients who received only medical treatment. Additionally, 38% of the spinal stimulation-group reported at least 30% improvement in back pain at six months versus 14% of the medically managed patients.&lt;/p&gt;
&lt;p&gt;Patients who were dissatisfied with their assigned treatment after six months were allowed to switch to the opposite therapy. Kumar reported that 30 of 50 patients in the medical group opted for spinal cord stimulation, compared with four of 50 in the spinal stimulation group who opted for continued treatment with medication alone.&lt;/p&gt;
&lt;p&gt;At 24 months, 42 of the original 50 patients remained in the spinal stimulation group, compared with 11 of 50 in the medical group. Differences observed at six months were maintained, including leg pain (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001), physical functioning (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0002), and quality of life (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001).&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Kumar disclosed relationships with Medtronic and Boston Scientific.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_346"
                     title="Daytime Sleepiness More Common in Young (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/PrimaryCare/SleepDisorders/tb/18221?impressionId=1265775730291"
                     
      &lt;p&gt;Compared with 20-somethings and seniors, middle-age adults are less likely to suffer daytime sleepiness when they don&apos;t get a good night&apos;s sleep, according to a small study.&lt;/p&gt;
&lt;p&gt;When three groups of healthy adults  --  young (20 to 30 years old), middle-age (40 to 55) and older (66 to 83)  --  were studied over four nights, slow wave sleep decreased and the number of nocturnal awakenings progressively increased with age, wrote Derk-Jan Dijk, PhD, of the Surrey Sleep Center at the University of Surrey in Guildford, England, and colleagues in the Feb. 1 issue of &lt;em&gt;Sleep.&lt;/em&gt;&lt;/p&gt;

&lt;p&gt;As the likelihood for eight hours of uninterrupted deep sleep decreased with age, there was no increase in the likelihood of daytime sleepiness, which led Dijk and colleagues to conclude that as people age there may be a change in the &quot;sleep (duration and depth) required to maintain alertness.&quot;&lt;/p&gt;
&lt;p&gt;Based on that observation, the authors wrote that it could be argued that &quot;an eight-hour episode rich in [slow wave sleep] is insufficient for young adults but that an eight-hour sleep episode with less [slow wave sleep] is sufficient for older adults.&quot;&lt;/p&gt;
&lt;p&gt;As a result, middle-age and older adults are less likely to build up &quot;sleep debt&quot; during the daylight hours, so they manage with less time in deep sleep at night, less homeostatic sleep pressure.&lt;/p&gt;
&lt;p&gt;The authors hypothesized that this apparent need for less sleep may be a factor in age-related insomnia.&lt;/p&gt;
&lt;p&gt;If older adults are unaware of the need for less sleep, &quot;their self-selected time in bed, which provides an input to the sleep homeostat, may become maladaptive and lead to reduced sleep consolidation and associated complaints.&quot;&lt;/p&gt;
&lt;p&gt;Dijk and colleagues recruited 44 young adults, 35 middle-age adults, and 31 older adults for their study. All were healthy at baseline and all were initially assessed for an eight-hour nocturnal sleep episode.&lt;/p&gt;
&lt;p&gt;They were then randomized to two nights of either selective short wave sleep interruption by acoustic stimuli or sleep without disruption, followed by one night of recovery sleep.&lt;/p&gt;
&lt;p&gt;Two standardized measurement tools, the Multiple Sleep Latency Test (MSLT) and the Karolinska Sleepiness Scale (KSS), were used to assess objective and subjective sleep propensity.&lt;/p&gt;
&lt;p&gt;&quot;Total sleep time per eight hour time in bed decreased significantly and progressively across the age groups such that older adults slept approximately 20 minutes less than middle-aged, who slept 23 minutes less than young adults,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;The reduction in total sleep time &quot;was primarily related to an increase in the number of awakenings and the duration of wakefulness after sleep onset, rather than an increase in latency to sleep onset.&quot;&lt;/p&gt;
&lt;p&gt;As a result, sleep efficiency decreased significantly from 92.1% for the youngest group, to 82% for the older group (effect of age, &lt;em&gt;P&amp;lt;&lt;/em&gt;0.0001).&lt;/p&gt;
&lt;p&gt;The subjective sleep propensity tests revealed that &quot;young people were significantly sleepier than the middle-age people, who were the least sleepy of the three groups.&quot; Daytime sleepiness for the oldest group &quot;fell in between the other two groups [and] was not significantly different from either.&quot;&lt;/p&gt;
&lt;p&gt;All three groups, regardless of age, demonstrated increased daytime sleepiness following a night of experimental disruption of slow wave sleep, but when the participants had an uninterrupted eight hours of deep sleep, it was only the youngest group that was drowsy during the daytime hours.&lt;/p&gt;
&lt;p&gt;The authors noted that although there was less daytime sleepiness among middle-age and older adults in this study, sleep propensity was not measured during the evening hours, so it was possible that the age-related difference might diminish at twilight.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was sponsored by H. Lundbeck A/S.&lt;/p&gt;&lt;p&gt;Dijk reported receiving research support from the Air Force Office of Scientific Research, the Biotechnology and Biological Sciences Research Council, GlaxoSmithKline, H. Lundbeck A/S, Merck, Pfizer, Philips Lighting, sanofi-aventis, and Takeda.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_296"
                     title="FDA Okays Morphine for Tolerant Patients"
                     score="0.005"
                     href="http://www.medpagetoday.com/PainManagement/PainManagement/tb/18157?impressionId=1265775730291"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first high-concentration, oral morphine sulfate solution as part of its unapproved drugs initiative.&lt;/p&gt;
&lt;p&gt;The drug is indicated for opioid-tolerant patients with moderate-to-severe acute and chronic pain, as well as end-of-life care.&lt;/p&gt;
&lt;p&gt;Opioid tolerance was defined as a patient using 60 mg of an opioid per day, Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesics, and Rheumatoid Products at the Center for Drug Evaluation and Research, said in a conference call.&lt;/p&gt;
&lt;p&gt;The new solution is available in 100 mg per 5 mL and 20 mg per 1 mL concentrations.&lt;/p&gt;
&lt;p&gt;Although morphine use in pain management has been a common practice, this form and concentration of the drug was not previously FDA approved.&lt;/p&gt;
&lt;p&gt;Approval for the new drug was based on efficacy and safety data already available, which applicants can use when seeking approval for unapproved formulations of drugs with a known safety profile, Hertz said.&lt;/p&gt;
&lt;p&gt;The FDA initiated the unapproved drugs initiative in March, 2009, when it sent warning letters to nine companies requesting they pull a number of morphine sulfate, oxycodone, and hydromorphone products from the market. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; target=&quot;_blank&quot;&gt;FDA Acts Against Unapproved Narcotic Drugs&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Seven of the warned companies produced unapproved concentrated morphine sulfate, but the FDA granted a reprieve from the initiative when it could not find a suitable approved replacement for the drug without disrupting patient care. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; target=&quot;_blank&quot;&gt;FDA Gives Temporary Reprieve to Unapproved Morphine Elixir&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The agency worked with manufacturer Roxane Laboratories to ensure that a sufficient supply of the drug was available and to develop a prescription and use guide for the medication.&lt;/p&gt;
&lt;p&gt;As part of the approval, the manufacturer needed to establish a safety profile prior to approval to address the risks of morphine misuse, abuse, and overdose.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>