Med Check
FDA to Release REMS Plan for Prescribers of Immediate-Release Opioids
In remarks delivered in July before the Food and Drug Administration (FDA) Scientific Meeting on Opioids, FDA Commissioner Scott Gottlieb announced that the FDA’s risk-management requirements that apply to extended-release opioid formulas will now be extended to include immediate-release opioid drugs.
The FDA’s Risk Evaluation and Mitigation Strategy (REMS) requires companies that manufacture opioids to educate prescribers on issues such as assessing patients’ pain, managing opioid use, and recognizing addiction when it arises.
“This regulatory tool is needed to ensure that the benefits of how these drugs are prescribed continue to outweigh the risks of misuse, abuse, addiction, overdose, and death,” Gottlieb said.
As part of the new requirements for immediate-release opioids, manufacturers must also include information on rival nonopioid pain therapies and nonpharmacological approaches to pain relief.
REMS courses are considered continuing medical education but are not mandatory for doctors, but Gottleib noted the agency is considering adding requirements for prescribers as well.
These latest measures come on the heels of the FDA’s request that Endo Pharmaceuticals pull its extended-release opioid, Opana ER, from the market, in addition to numerous city and state lawsuits filed against opioid companies.
Commissioner Gottlieb stated that opioid manufacturers will get details on next steps soon. “[R]elevant letters, detailing the new requirements, will be sent to IR [immediate-release] manufacturers in the coming weeks,” he said.
NDA Resubmitted for Aripiprazole-Ingestible Sensor Combination
Otsuka Pharmaceutical Co. Ltd. and Proteus Digital Health have resubmitted a New Drug Application (NDA) for their “digital medicine” that combines Abilify (aripiprazole) with a tiny ingestible sensor in a single tablet.
The FDA declined the original NDA submission in May 2016, requesting additional information on this medicine’s performance under the conditions in which it is likely to be used as well as additional evaluation on any risks of this combination therapy.
Proteus’s ingestible sensor, which was approved by the FDA in 2015, is activated by stomach fluids and communicates select physiological data via a wearable sensor. These data are then transmitted to a mobile application that a patient can view and share with a health care professional to inform medical decision making and improve adherence.
The FDA is expected to review the resubmitted NDA and take action by the end of this year.
Olanzapine-Samidorphan Combination Shows Promise in Phase 3 Trial
Alkermes in late June announced positive preliminary results from a phase 3 clinical study of its candidate schizophrenia drug ALKS 3831—an oral formulation that combines olanzapine with the opioid antagonist samidorphan.
Olanzapine is known to increase the risk of weight gain and Type 2 diabetes. ALKS 3831 is designed to provide the antipsychotic efficacy of olanzapine without the metabolic effects of the medication.
The phase 3 study, known as ENLIGHTEN-1, was a four-week, hospital-based study that compared ALKS 3831 with placebo and olanzapine in 403 patients with acute schizophrenia. At the four-week mark, ALKS 3831 performed as well as olanzapine and significantly better than placebo at reducing baseline symptoms as measured by both the Positive and Negative Syndrome Scale scores and Clinical Global Impression–Severity rating scale.
The next hurdle is determining whether side effects are improved, which is currently ongoing with ENLIGHTEN-2, a six-month study evaluating the weight gain profile of olanzapine compared with ALKS 3831. The results of this study are expected sometime in 2018.
Study Supports Potential of Naltrexone as Adjunct for ADHD Stimulants
Adjunctive naltrexone does not interfere with the clinical or side effect profile of methylphenidate in people with attention-deficit/hyperactivity disorder (ADHD), according to a study published in the Journal of Clinical Psychiatry in June. The finding suggests that combining opioid receptor antagonists such as naltrexone with stimulants might reduce the abuse potential of methylphenidate and other stimulants.
The study involved 37 adults with ADHD who experienced stimulant-induced euphoria after being given a test dose of immediate-release methylphenidate. Participants were randomly assigned to receive twice-daily extended-release methylphenidate in combination with 50 mg naltrexone or placebo over six weeks.
After six weeks, the group taking naltrexone and methylphenidate did not show any differences in clinical symptoms compared with the control group (as measured by the Adult ADHD Investigator Symptom Report Scale), suggesting the same level of methylphenidate effectiveness. Additionally, the combination of naltrexone and methylphenidate did not produce an increase in adverse events compared with methylphenidate alone.
NGF Inhibitor Receives Fast-Track Designation for Treatment of Chronic Pain
Pfizer and Eli Lilly recently announced that the FDA has given a fast-track designation to the nerve growth factor (NGF) inhibitor tanezumab for the treatment of chronic pain in patients with osteoarthritis and chronic low back pain.
Tanezumab is an antibody that works by selectively binding to and inhibiting NGF, which is elevated in response to injury, inflammation, and chronic pain. By inhibiting NGF, tanezumab may help prevent pain signals produced in peripheral tissues from reaching the spinal cord and brain.
Tanezumab is currently being tested in a phase 3 clinical program that includes six trials and approximately 7,000 patients with osteoarthritis, chronic low back pain, or cancer pain. Results are expected sometime in 2018.
Multiple companies have been trying to develop NGF inhibitors as analgesics, though this class of drugs has had many setbacks. Last year, the drug candidate fasinumab was placed under a clinical hold by the FDA due to concerns of joint damage. ■
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Published online: 3 August 2017
Published in print: July 22, 2017 – August 4, 2017
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