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The Medicines Company Announces FDA Approval of IONSYS® (fentanyl iontophoretic transdermal system) for the Management of Acute Post-Operative Pain for Adult Patients in the Hospital

IONSYS® is the first needle-free, patient-controlled, pre-programmed fentanyl delivery system

PARSIPPANY, N.J.--(BUSINESS WIRE)--Apr. 30, 2015-- The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has approved IONSYS® (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.

A recent survey of post-surgical patients indicates that of the more than 51 million in-patient surgeries performed annually in the U.S., approximately 65 percent of post-operative patients experience moderate-to-severe pain.1, 2 According to an 2012 analysis of the Premier Hospital Database, 1.4 million patients manage their pain with intravenous patient-controlled analgesia (IV-PCA).3 However, acute post-operative pain continues to be a concern for patients, as 53 percent of patients surveyed in the hospital reported anxiety about their post-operative pain.4

IONSYS offers patients recovering from surgery in the hospital control over their analgesic dosing by pushing a button to dispense fentanyl transdermally via an imperceptible electrical current as needed for pain. IONSYS will only be administered to patients in hospitals enrolled in the IONSYS Risk Evaluation Mitigation Strategy (REMS) program and is not intended for home use. The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed.

“IONSYS is a novel alternative to traditional IV-PCA providing needle-free delivery of opioid analgesia with a credit-card-sized, self-adherent device employing an imperceptible electric current to deliver on-demand fentanyl,” said Eugene R. Viscusi, MD, Professor of Anesthesiology and Director, Acute Pain Management at Thomas Jefferson University in Philadelphia. “IONSYS fits well in a multi-modal analgesic approach allowing opioid administration as a complement to other non-opioid based therapies. The simplicity of this device may make patient mobility and physical therapy easier while reducing the potential burdens associated with a programmable pump.”

According to a survey of 351 nurses and 507 patients presented at an American Society of PeriAnesthesia Nurses (ASPAN) conference, 63 percent of nurses and 56 percent of patients said lack of mobility is a drawback of IV-PCA. Among the nurses surveyed, 84 percent said that having the option of a needle-free postoperative pain management system would improve their ability to care for their patients.5

“An important concern for nurses treating post-operative patients is the efficiency with which they are able to administer patient-controlled analgesia,” said Cecile R. Pestano, RN, BSN, CCRP, Nurse Manager, Clinical Research, Beaumont Health System. “IONSYS has the potential to optimize nursing care for post-operative patients, resulting in a high degree of nurse satisfaction, while also improving patient mobility.”

“IONSYS represents a novel treatment and potential cornerstone in the management of patients with acute post-operative surgical pain,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. “Here’s what’s possible: we believe IONSYS has the potential to change the management of pain in the hospital. With patient satisfaction increasingly being directly linked to hospital reimbursement, it is critical for hospitals to have effective pain management options available for their post-surgical patients.”

“This latest approval serves as a key part of our company ‘s purpose, which is to contribute to the economic efficiencies of healthcare by providing value-based therapies to hospitals.”

The Medicines Company expects IONSYS to be available in the U.S. in Q3 2015.

The Company will discuss this approval in its quarterly earnings call on May 5th at 8:30 am. The conference call will be available via phone and webcast. Dial –in information is listed below:

Domestic Dial-in: +1 (877) 359-9508

International Dial-in: +1 (224) 357-2393

Passcode for both dial-in numbers: 22764656

Replay is available from 11:30 am Eastern time following the conference call through May 12, 2015. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial-in numbers is 22764656.

This call is being webcast and can be accessed via The Medicines Company website at www.themedicinescompany.com.

About IONSYS® (fentanyl iontophoretic transdermal system), CII

IONSYS contains the opioid fentanyl and is a compact, needle-free, pre-programmed system that is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia in the hospital. IONSYS is only for use in patients who are alert enough and have adequate cognitive ability to understand the directions for use. IONSYS is not for home use and is intended for use only in patients in the hospital. Discontinue treatment with IONSYS before patients leave the hospital. IONSYS is for use after patients have been titrated to an acceptable level of analgesia using alternate opioid analgesics.

IONSYS will only be administered to patients in hospitals enrolled in the IONSYS REMS program, the goal of which is to decrease the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by ensuring it is only dispensed to patients in certified hospitals and informing health care providers of the serious risk of respiratory depression resulting from accidental exposure to fentanyl.

The efficacy of IONSYS was established in three placebo-controlled trials, while safety was established in three placebo-controlled trials and four additional active-controlled randomized trials.

Important Safety Information

WARNING: HOSPITAL USE ONLY; LIFE-THREATENING RESPIRATORY DEPRESSION; IONSYS REMS; ADDICTION, ABUSE, AND MISUSE; and CYTOCHROME P450 3A4 INTERACTION

 

Life Threatening Respiratory Depression

 

  • Use of IONSYS may result in potentially life-threatening respiratory depression and death as a result of the active drug, fentanyl. Only the patient should activate IONSYS dosing.
  • Accidental exposure to an intact IONSYS or to the hydrogel component, especially by children, through contact with skin or contact with mucous membranes, can result in a fatal overdose of fentanyl.
  • Keep out of reach of children.
  • IONSYS is for use only in patients in the hospital. Discontinue treatment with IONSYS before patients leave the hospital.

IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program

 

  • Because of the of potentially life-threatening respiratory depression resulting from accidental exposure, IONSYS is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Hospitals must enroll in the program before they can dispense IONSYS. Further information is available at www.ionsysrems.com, or by calling 1-877-488-6835.

Addiction, Abuse, and Misuse

 

  • IONSYS contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
  • IONSYS exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.

 

Cytochrome P450 3A4 Interaction

 

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

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma
  • Known or suspected paralytic ileus and GI obstruction
  • Hypersensitivity to fentanyl or cetylpyridinium chloride (e.g., Cepacol®) or any component of IONSYS

Warnings and Precautions

  • Interactions with CNS depressants: Concomitant use with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, otheropioids) may cause hypotension, profound sedation, respiratory depression, coma and death. Monitor patients closely if co-administration is required.
  • Risk of Injury During MRI Procedure: IONSYS contains metal parts and must be removed and properly disposed of before an MRI procedure.
  • Radiographic Imaging, Cardioversion, Defibrillation, Pacemakers: IONSYS contains metal parts and must be removed and properly disposed of before cardioversion or defibrillation to avoid damage to IONSYS from the strong electromagnetic fields set up by these procedures. IONSYS contains radio-opaque components and may interfere with an X-ray image or CAT scan.
  • Topical Skin Reactions: Topical skin reactions may occur with use of IONSYS and are typically limited to the site application area. Reactions generally resolve without treatment. If a severe skin reaction is observed, remove IONSYS and discontinue further use.
  • Use in Elderly, Cachectic, and Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Monitor such patients closely when IONSYS is used concomitantly with other drugs that depress respiration.
  • Use in Patients with Chronic Pulmonary Disease: Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy with IONSYS. Consider the use of alternative non-opioid analgesics in these patients if possible.
  • Hypotensive Effect: IONSYS may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume, or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients after initiating IONSYS. In patients with circulatory shock, IONSYS may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of IONSYS in patients with circulatory shock.
  • Patients with Head Injury or Increased Intracranial Pressure: IONSYS is not suitable for use in patients who are not alert and able to follow directions. Monitor for sedation and respiratory depression. Avoid use of IONSYS in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention. IONSYS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may obscure the clinical course of patients with head injury. Use IONSYS with caution in patients with brain tumors.
  • Use in Patients with Gastrointestinal Conditions: IONSYS is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. Fentanyl may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms. Opioids may cause increases in serum amylase.
  • Use in Patients with Convulsive or Seizure Disorders: IONSYS may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during IONSYS therapy.
  • Cardiac Disease: IONSYS may produce bradycardia in some patients. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with IONSYS.
  • Hepatic Impairment: Insufficient data are available on the use of IONSYS in patients with impaired hepatic function. Monitor for signs of sedation and respiratory depression in patients with hepatic impairment.
  • Renal Impairment: A clinical pharmacology study with intravenous fentanyl in patients undergoing kidney transplantation has shown that patients with high blood urea nitrogen level had low fentanyl clearance. Monitor for signs of sedation and respiratory depression in patients with renal impairment.

Adverse Reactions

Most common (frequency ≥ 2%) headache, hypotension, nausea, vomiting, anemia, dizziness, application site reaction-erythema, pruritus, and urinary retention.

About The Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

Forward-Looking Statements

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," “hopes” and “potential” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision makers will accept clinical trial results; the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do; the Company’s specific annual allocation quota of fentanyl hydrochloride by the U.S. Drug Enforcement Administration; whether third parties on whom the Company relies to manufacture and support the development and commercialization of Ionsys are able to fulfill their obligations or the Company is able to establish or maintain such arrangements; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

1 Centers for Disease Control and Prevention, In-Patient Surgery. http://www.cdc.gov/nchs/fastats/inpatient-surgery.htm.

2 Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014;30(1):149-160

3 Premier Hospital Database 2012

4 Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014;30(1):149-160

5 The American Society of PeriAnesthesia Nurses (ASPAN) and Ortho-McNeil, Inc. 2007 Survey: http://www.aspan.org/About-Us/News-Room/Archived-News-Room/February-13-2007.

Source: The Medicines Company

Media:
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Neera.Ravindran@themedco.com