Pain Management Medication Approved by FDA in 2016-2017

This article originally appeared here.
Share this content:
The presenters reported that AceIRx Pharmaceuticals has submitted a new drug application for sublingual sufentanil
The presenters reported that AceIRx Pharmaceuticals has submitted a new drug application for sublingual sufentanil

LAS VEGAS — A program offered at PAINWeek 2017, held September 5-9, covered new medications that were introduced to the market or approved by the US Food and Drug Administration (FDA) in 2016 and 2017. The presenters were Mary Lynn McPherson, PharmD, a professor and executive director of the Advanced Post-Graduate Education in Palliative Care in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy, and Alexandra L. McPherson, PharmD, MPH, a postgraduate year 2 pharmacy practice resident there.1

They reviewed new drugs indicated for central nervous system and gastrointestinal disorders, infection, cancer treatment, and diabetes. Here are new agents they singled out, which are indicated for pain management:

  • Belbuca (buprenorphine) is a partial opioid agonist in a buccal film formulation that is indicated for severe pain requiring continuous, long-term opioid treatment. It is available in doses ranging from 75 to 900 μg, with cost ranging from approximately $250 for the lowest dose to $700 for the highest dose.
  • Probuphine is a rod-shaped, subdermal buprenorphine implant that provides buprenorphine delivery for up to 6 months. It is indicated as maintenance treatment for opioid-dependent patients with stable abstinence receiving 8 mg or less buprenorphine daily. Results from randomized controlled trials show that 8 mg probuphine is noninferior to sublingual buprenorphine, 8 mg daily.2 In addition, 96.4% of patients in the probuphine group remained free of illicit opioid use for at least 4 months (the primary outcome) compared with 87.6% of those in the sublingual group.2 The approximate cost is $4950 vs $1672 for generic, daily buprenorphine.
  • XTAMPZA ER is an extended-release, abuse-deterrent form of oxycodone indicated for severe pain requiring daily opioid treatment. It is "a capsule containing microspheres formulated with oxycodone base and inactive ingredients that make it more difficult to manipulate and abuse." The drug is available in strengths ranging from 9 mg (equivalent to 10 mg oxycodone hydrochloride) to 36 mg (equivalent to 40 mg oxycodone hydrochloride), and its oral bioavailability increases by 100% to 150% if taken with a high-fat meal. The cost ranges from $430 to $730 per month.
  • Vantrela ER (hydrocodone bitartrate) and Arymo ER (morphine sulfate) are 2 new abuse-deterrent formulations aimed at reducing abuse when the tablets are manipulated.
  • Troxyca ER is an extended-release formulation of oxycodone and naltrexone indicated for severe pain requiring daily, long-term opioid treatment. It carries the risk for the typical adverse effects associated with opioids. Information about its cost is unavailable.

Other new drugs of interest for pain practitioners include Vivlodex, a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam for the management of osteoarthritis pain, and Intrarosa (prasterone), a vaginal insert to treat painful vaginal intercourse associated with menopause.

Also discussed was the first-in-class opioid analgesic NKTR-181, a long-acting, selective μ-opioid agonist that demonstrated positive top-line results for the treatment of chronic back pain, as announced in July 2017.3 It is designed to reduce adverse effects associated with opioids (eg, euphoria), which can lead to abuse and dependence.

In addition, the presenters reported that AceIRx Pharmaceuticals has submitted a new drug application for sublingual sufentanil, which is intended to provide relief within 15 minutes for moderate to severe acute pain. The drug would be administered in a clinical setting via a prefilled, single-dose applicator.

"We continue to develop abuse-deterrent opioid formulations, and I think the peripherally acting μ-opioid receptor antagonists continue to be pharmacologically very interesting," although both are associated with substantial cost, Dr McPherson told Clinical Pain Advisor. She noted that "pain and palliative care practitioners need to stay abreast of not only pain and palliative care drugs, but all new drugs, because they impact the entire medication regimen."

Read more of Clinical Pain Advisor's coverage of PAINWeek 2017 by visiting the conference page.

follow @RheumAdvisor

References

  1. McPherson ML, McPherson AL. New drugs in pain management and palliative care. Presented at PAINWeek 2017; September 5-9, 2017; Las Vegas, NV.
  2. Rosenthal RN, Lofwall MR, Kim S, Chen M, Beebe KL, Vocci FJ; PRO-814 Study Group. Effect of buprenorphine implants on illicit opioid use among abstinent adults with opioid dependence treated with sublingual buprenorphine: a randomized clinical trial. JAMA. 2016;316(3):282-290. doi: 10.1001/jama.2016.9382
  3. PR Newswire. Nektar announces topline data from human abuse potential study for NKTR-181, a first-in-class investigational opioid to treat chronic pain. 2017. Available at: http://www.prnewswire.com/news-releases/nektar-announces-topline-data-from-human-abuse-potential-study-for-nktr-181-a-first-in-class-investigational-opioid-to-treat-chronic-pain-300489675.html. Accessed September 6, 2017.
You must be a registered member of Rheumatology Advisor to post a comment.
.

Sign Up for Free e-newsletters