Breaking News
November 20, 2018 - Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
November 20, 2018 - Arthritis by the Numbers: Book of Trusted Facts & Figures
November 20, 2018 - Drug homing method helps rethink Parkinson’s
November 20, 2018 - AHF commends the passage of global AIDS funding in the House, calls for swift approval
November 20, 2018 - The search for new psychiatric disorder treatments
November 20, 2018 - New research offers hope for simpler way to diagnose and treat cancer
November 20, 2018 - Study sheds light on the infection mechanism of influenza virus
November 20, 2018 - Storage failures of eggs and embryos gain a new perspective
November 20, 2018 - Buyers of short-term health plans: Wise or shortsighted?
November 20, 2018 - Study indicates that frogs in virus-exposed groups breed at young age
November 20, 2018 - FDA Alerts Health Care Professionals and Patients Not To Use Sterile Drug Products from Pharm D Solutions
November 20, 2018 - Asthma may contribute to childhood obesity epidemic
November 20, 2018 - Researchers to explore the enigmatic role of unstructured protein in regulating circadian function
November 20, 2018 - Drug used to treat PTSD does not reduce suicidal thinking, may worsen nightmares and insomnia
November 20, 2018 - In-person social contact may offer protection against depression and PTSD symptoms
November 20, 2018 - Routine HCV testing in correctional facilities can best identify and treat disease, say researchers
November 20, 2018 - Molecular DNA analysis could facilitate more accurate prognosis, treatment of aggressive brain tumors
November 20, 2018 - Breast Cancer Recurrence Rate Not Up With Autologous Fat Transfer
November 20, 2018 - Beta 2 Microglobulin (B2M) Tumor Marker Test: MedlinePlus Lab Test Information
November 20, 2018 - Could bariatric surgery make men more virile?
November 20, 2018 - Urine test to check if patients take their medications will save the NHS money, say researchers
November 20, 2018 - Study reveals impact of residual inflammatory risk on clinical outcomes after PCI
November 20, 2018 - RNAi therapy shown to alleviate preeclampsia
November 20, 2018 - Replacement of dysfunctional microglia has therapeutic potential for neurodegenerative diseases
November 20, 2018 - Forming 3D Neuronal Models of the Brain
November 20, 2018 - Shoulder ultrasounds could be used to predict diabetes
November 20, 2018 - SGLT2 Inhibitors for Diabetes Linked to Increased Risk for Amputation
November 20, 2018 - Stem cell transplant cements Arizona men’s father-son bond
November 20, 2018 - Scientists try to develop portable systems that can quickly produce biologics on demand
November 20, 2018 - Automating Data Capture and Image Analysis in Continuous Experiments
November 20, 2018 - New drug shows promise for treating people with peanut allergy
November 20, 2018 - Researchers develop novel mouse model to study immunomodulatory therapies
November 20, 2018 - “Britain must not go backward on antibiotic controls to appease US trade deals” – Jim Moseley, CEO of Red Tractor
November 20, 2018 - Widespread errors in ‘proofreading’ cause inherited blindness
November 20, 2018 - Reaping the benefits of living longer
November 20, 2018 - New Program Hopes to Make Early Detection and Treatment of ALS a Reality
November 19, 2018 - Artificial bone-like substance mimics the way real bone grows at atomic level
November 19, 2018 - FDA Grants Orphan Drug Designation To RGX-181 Gene Therapy For The Treatment Of CLN2 Form Of Batten Disease
November 19, 2018 - Systemic mastocytosis – Genetics Home Reference
November 19, 2018 - Eye trauma secondary to falls in older adults increasing
November 19, 2018 - Empowering women in India to improve their health: A Q&A
November 19, 2018 - Researchers have trained a computer to analyze breast cancer images and classify tumors
November 19, 2018 - New glucose binding molecule could be key to better metabolic control for diabetics
November 19, 2018 - Biologists uncover novel genetic control of lipid maintenance and its potential connection to lifespan
November 19, 2018 - Warmer winters may set scene for higher rates of violent crimes
November 19, 2018 - Personalized program of physical exercise effective in reversing functional decline in the elderly
November 19, 2018 - Acacia Pharma Resubmits Barhemsys New Drug Application
November 19, 2018 - PDL1 (Immunotherapy) Tests: MedlinePlus Lab Test Information
November 19, 2018 - Transforming pregnancy research with a smartphone app
November 19, 2018 - Stanford Medicine magazine explores how digital technology is changing health care
November 19, 2018 - Vision impairments may increase risk of falls in older adults
November 19, 2018 - Concomitant use of sleeping pills and opioids found to prevalent among people with Alzheimer’s disease
November 19, 2018 - Marijuana prevention programs should focus on promoting mental wellbeing of youth
November 19, 2018 - New report calls for greater awareness and emphasis on scale and impact of atrial fibrillation
November 19, 2018 - In throes of turkey salmonella outbreak, don’t invite illness to your table
November 19, 2018 - UK health policies should be redesigned to become more accessible for men
November 19, 2018 - Short Interpregnancy Intervals Tied to Adverse Outcome Risk
November 19, 2018 - New mothers’ breastfeeding pain can affect infant health
November 19, 2018 - Stanford Medicine magazine reports on ways digital technology is transforming health care | News Center
November 19, 2018 - Human drugs alter cricket personality
November 19, 2018 - Insilico Medicine to introduce ‘Cure a disease in a year’ program at Biodata World Congress 2018
November 19, 2018 - Experts debate over whether gut or brain is more important in regulating appetite
November 19, 2018 - Playing on fear and fun, hospitals follow pharma in direct-to-consumer advertising
November 19, 2018 - 2PG Company receives grant to develop sensitive, low-cost molecular diagnostic tests for tuberculosis
November 19, 2018 - Low-Carb Diets May Work By Boosting Calorie Burn
November 19, 2018 - Key molecule responsible for learning and memory discovered
November 19, 2018 - New blood test developed for early diagnosis of ovarian cancer
November 19, 2018 - Researchers identify molecule to fight myotubular myopathy
November 19, 2018 - New solution to stop spread of brain cancer
November 19, 2018 - Immune cells trigger OCD-like behaviour in multiple sclerosis, study finds
November 19, 2018 - Scientists equip new virus that kills carcinoma cells with protein
November 19, 2018 - Novel approach could provide painless, efficient alternative for treating eye diseases
November 19, 2018 - Protein in cell membranes of sperm plays key role in finding their way to eggs
November 19, 2018 - Parents who decline flu vaccination for their child may be exposed to limited information
November 19, 2018 - Mirati Presents Data From Ongoing Phase 2 Clinical Trial Of Mocetinostat In Combination With Durvalumab At The SITC 33rd Annual Meeting
November 19, 2018 - FDA warns of common diabetes meds’ link to dangerous genital infection
November 19, 2018 - New methods for preserving shoulder function, quality of life in breast cancer patients
November 19, 2018 - Surprising discovery about BH4 may rekindle interest in once-promising pathway
November 19, 2018 - Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous Contepo to Treat Complicated Urinary Tract Infections
November 19, 2018 - Beating breast cancer only to die of opioid use – a sad Appalachian story
FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain

FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain

image_pdfDownload PDFimage_print

FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain

REDWOOD CITY, Calif., Nov. 2, 2018 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced today the approval of Dsuvia by the U.S. Food and Drug Administration (FDA). Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

“The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer, AcelRx. “As an anesthesiologist, I’ve seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients’ acute pain.”

Dsuvia is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a healthcare professional only in certified medically supervised settings. In a randomized, double-blind, placebo-controlled clinical study, Dsuvia demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. The pain intensity difference from baseline was superior to that of the placebo group within 15 minutes and median meaningful pain relief occurred following a single dose. The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse and diversion. The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with difficult IV access (obese, elderly, burn or needle-phobic patients). Avoiding an IV has the potential to offer efficiency improvements in healthcare settings and improve patient experience. There are an estimated 92 million annual adult patient visits to medically supervised settings for moderate-to-severe acute pain. An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.1

“Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research. “As a single-dose, non-invasive medication with a rapid reduction in pain intensity, Dsuvia represents an important alternative for healthcare providers to offer patients for acute pain management.”

“The approval of Dsuvia, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” said Vince Angotti, Chief Executive Officer, AcelRx. “We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program.”

The Dsuvia commercial launch is expected in the first quarter of 2019.

Dsuvia efficacy and safety information

The efficacy and safety of Dsuvia were evaluated in one randomized, double-blind, placebo-controlled trial which enrolled 161 patients (age 18 to 69 years) with acute postoperative pain (pain intensity of ≥ 4 on a 0-10 numeric rating scale) after abdominal surgery (studied up to 48 hours). Patients were dosed with Dsuvia 30 mcg or placebo as needed with a minimum of 60 minutes between doses. Morphine sulfate 1 mg IV was available as rescue medication.

Patients using Dsuvia had a statistically significantly greater SPID12 than patients using placebo. Approximately 22% of patients in the Dsuvia group and 65% of patients in the placebo group took rescue medication within the first 12 hours of the treatment phase.

In controlled and uncontrolled studies, the safety of Dsuvia was evaluated in a total of 646 patients with moderate-to-severe postoperative pain or pain due to trauma which required opioid analgesia. The most frequently reported adverse reactions ≥ 2% in the randomized, placebo-controlled trial were nausea, headache, vomiting, dizziness, and hypotension. The Dsuvia clinical program builds upon the established safety and efficacy of the reference product, sufentanil citrate injection, which has been in commercial use for over three decades.

Dsuvia will not be available in retail pharmacies or for outpatient use. Dsuvia will only be distributed to health care settings certified in the Dsuvia Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of Dsuvia. As part of the REMS program, AcelRx will monitor distribution and audit wholesalers’ data, evaluate proper usage within the healthcare settings and monitor for any diversion and abuse. Additionally, AcelRx will de-certify healthcare settings that are non-compliant with the REMS program.

About Dsuvia (sufentanil sublingual tablet, 30 mcg)

Dsuvia, known as Dzuveo outside the United States, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Dsuvia was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. Dsuvia is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018. For more information, please visit www.Dsuvia.com.

LIMITATIONS OF USE

Not for home use or for use in children. Discontinue treatment with Dsuvia before patients leave the certified medically supervised healthcare setting. Not for use for more than 72 hours. The use of Dsuvia beyond 72 hours has not been studied. Only to be administered by a healthcare provider.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Dsuvia for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.

The Full Prescribing Information for Dsuvia contains the following Boxed Warning:

WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM: LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Accidental Exposure and Dsuvia REMS Program: Accidental exposure to or ingestion of Dsuvia, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, Dsuvia is available only through a restricted program called the Dsuvia REMS Program. Dsuvia must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of Dsuvia prior to discharge or transfer from the certified medically supervised setting.

Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with the use of Dsuvia. Monitor for respiratory depression, especially during initiation of Dsuvia.

Addiction, Abuse, and Misuse: Dsuvia exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing Dsuvia, and monitor all patients regularly for the development of these behaviors or conditions.

Cytochrome P450 3A4 Interaction: The concomitant use of Dsuvia with cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving Dsuvia and any CYP3A4 inhibitor or inducer.

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants: “Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

IMPORTANT SAFETY INFORMATION

Dsuvia is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and known hypersensitivity to sufentanil or components of Dsuvia.

Dsuvia contains sufentanil, a Schedule II controlled substance. As an opioid, Dsuvia exposes users to the risks of addiction, abuse, and misuse. Potential serious adverse events caused by opioids include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal withdrawal syndrome, risks of concomitant use or discontinuation of cytochrome P450 3A4 inhibitors and inducers, risks from concomitant use with benzodiazepines or other CNS depressants, risk of life threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, adrenal insufficiency, severe hypotension, risks of use in patients with increased intracranial pressure or impaired consciousness, gastrointestinal disorders and seizure disorders. Dsuvia should be used with caution in patients with severe liver or kidney impairment.

For Important Safety Information including full prescribing information, visit: www.Dsuvia.com.

Clinical and Rehabilitative Medicine Research Program (CRMRP)

Dsuvia is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries. In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., Dsuvia (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

For additional information about AcelRx, please visit www.acelrx.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to the safety, efficacy and tolerance of Dsuvia and the planned timing for the commercial launch of Dsuvia. These forward-looking statements are based on AcelRx’s current expectations and involve significant risks and uncertainties. AcelRx’s actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including, without limitation: any delays in the commercial launch of Dsuvia or the Company’s other approved products or the inability to maintain regulatory approval of Dsuvia in the United States, and other risks detailed in the “Risk Factors” and elsewhere in AcelRx’s U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K filed with the SEC on March 9, 2018 and Quarterly Report on Form 10-Q filed with the SEC on August 2, 2018. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations, except as required by law.

1 Source: Aggregated Medical Literature review, QuintilesIMS primary market research, QuintilesIMS analysis 2016. ARX-04 and Zalviso US data-December 2016.

SOURCE AcelRx Pharmaceuticals, Inc.

Posted: November 2018

Related Articles:

  • FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain – October 12, 2018
  • AcelRx Announces FDA Acceptance of NDA for DSUVIA – May 24, 2018
  • AcelRx Resubmits New Drug Application for DSUVIA – May 9, 2018
  • AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018 – March 8, 2018
  • AcelRx Pharmaceuticals Receives Complete Response Letter from the FDA for DSUVIA NDA – October 12, 2017
  • AcelRx Pharmaceuticals’ New Drug Application for DSUVIA Accepted for Filing – February 27, 2017
  • AcelRx Pharmaceuticals Provides Guidance on 2017 Milestones for ARX-04, now known as DSUVIA in the United States, for the Treatment of Moderate-to-Severe Acute Pain – January 8, 2017
  • AcelRx Pharmaceuticals Submits New Drug Application for ARX-04 for the Treatment of Moderate-To-Severe Acute Pain – December 13, 2016

Dsuvia (sufentanil) FDA Approval History

Tagged with:

About author

Related Articles