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 News Release - April 26, 2017

Inspirion Delivery Sciences Receives FDA Approval for RoxyBond(TM) (oxycodone hydrochloride) tablets CII, the First and Only Immediate Release Opioid Analgesic with Abuse-Deterrent Label Claims

BASKING RIDGE, N.J., April 26, 2017 -- (Healthcare Sales & Marketing Network) -- Inspirion Delivery Sciences, LLC ("Inspirion") announced that the United States Food and Drug Administration (FDA) has approved RoxyBond™ (oxycodone hydrochloride) tablets, for oral use, CII, indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is an abuse-deterrent formulation of oxycodone that uses physical and chemical barriers to deter abuse, without the use of aversive agents or opioid antagonists. RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties, consistent with the FDA's 2015 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. RoxyBond is approved in three dosage strengths: 5, 15, and 30mg.

RoxyBond, which uses Inspirion's SentryBond™ technology, is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse even if the tablet is subjected to physical manipulation and/or attempts at chemical extraction. Laboratory test data demonstrated that, relative to another approved oxycodone immediate-release tablet, RoxyBond has increased resistance to cutting, crushing, grinding, or breaking using selected tools. In addition, both intact and manipulated RoxyBond tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pre-treatments. Relative to oxycodone immediate-release tablets, the RoxyBond formulation forms a viscous material that resists passage through a needle; it was also more difficult to prepare solutions suitable for intravenous injection. The in vitro data demonstrate that RoxyBond has physicochemical properties expected to make abuse via injection difficult. However, abuse by the intranasal, oral, and intravenous route is still possible

A clinical abuse potential study was also conducted. "As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration," said Lynn R. Webster, MD, Principal Investigator, PRA Health Sciences, Salt Lake City, UT.

"RoxyBond represents the first and only immediate-release opioid approved by FDA with abuse-deterrent claims," said Jeffrey Gudin, MD, Department Director, Pain Management Center Englewood Hospital and Medical Center. Dr. Gudin went on to say, "Oxycodone immediate release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse."

"Inspirion is pleased to receive FDA approval for our second abuse deterrent product, RoxyBond, which is intended to address the long standing unmet need for immediate release abuse deterrent opioids. There are nearly 18 million prescriptions for immediate release oxycodone hydrochloride annually in the U.S. alone." said Stefan Aigner, MD, CFA, CEO of Inspirion.

On April 5, 2017, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration voted 19 to 0 (with one abstention) to recommend approval of RoxyBond.

PLEASE SEE IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND INDICATION BELOW

About Inspirion Delivery Sciences, LLC

Inspirion Delivery Sciences LLC is a privately held specialty pharmaceutical company that is dedicated to advancing solutions in the field of prescription drug abuse deterrence through continued innovation. Recognizing the serious unmet public health need to combat the escalating crisis of prescription opioid abuse and misuse, Inspirion began pioneering the development of novel abuse-deterrent technologies. For more information, visit the Company's website at www.inspirionds.com.

About SentryBond™

The SentryBond technology platform combines inactive excipients with active pharmaceutical ingredients (API) in a tablet that is specifically designed to frustrate abuse for various methods of manipulation and routes of administration while slowing of the intended immediate-release properties of RoxyBond when manipulated then insufflated compared to taking RoxyBond orally intact. SentryBond Technology imparts its abuse-deterrent characteristics via physical and chemical methods, without the use of antagonist or aversive agents. SentryBond technology is covered by an issued U.S. patent, with multiple U.S. and global patent applications pending.

INDICATION

RoxyBond (oxycodone hydrochloride) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve RoxyBond 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
IMPORTANT SAFETY INFORMATION

The full prescribing information for RoxyBond contains the following Boxed Warning:

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

RoxyBond exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing RoxyBond, and monitor all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of RoxyBond. Monitor for respiratory depression, especially during initiation of RoxyBond or following a dose increase.

Accidental Ingestion

Accidental ingestion of even one dose of RoxyBond, especially by children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of RoxyBond during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of RoxyBond with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse 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 oxycodone plasma concentration. Monitor patients receiving RoxyBond 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 of RoxyBond and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.
DRUG ABUSE AND DEPENDENCE

RoxyBond contains oxycodone, a Schedule II controlled substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, oxymorphone, and tapentadol. RoxyBond can be abused and is subject to misuse, addiction, and criminal diversion.

All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

RoxyBond is for oral use only. Abuse of RoxyBond poses a risk of overdose and death. This risk is increased with concurrent abuse of RoxyBond with alcohol and other central nervous system depressants.

CONTRAINDICATIONS

RoxyBond is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia, known or suspected gastrointestinal obstruction, including paralytic ileus, and known hypersensitivity (e.g., anaphylaxis) to oxycodone.

ADDITIONAL WARNINGS AND PRECAUTIONS

Patients with Chronic Pulmonary Disease: RoxyBond-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of RoxyBond.

Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor patients closely, particularly when initiating and titrating RoxyBond and when RoxyBond is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.

Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.

Severe Hypotension: RoxyBond 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 for signs of hypotension after initiating or titrating the dosage of RoxyBond. In patients with circulatory shock, use of RoxyBond may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid use of RoxyBond in patients with circulatory shock.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), RoxyBond may reduce the respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with RoxyBond. Opioids may obscure the clinical course in a patient with a head injury. Avoid the use of RoxyBond in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions: The oxycodone in RoxyBond may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders: The oxycodone in RoxyBond may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during RoxyBond therapy.

Risks of Driving and Operating Machinery: RoxyBond may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of RoxyBond and knowhow they will react to the medication.

DRUG INTERACTIONS
  • The concomitant use of RoxyBond and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of RoxyBond and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of RoxyBond is achieved.
  • The concomitant use of RoxyBond and CYP3A4 inducers such as rifampin, carbamazepine, phenytoin can decrease the plasma concentration of oxycodone, resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed a physical dependence to oxycodone.
  • Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
  • The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
  • The concomitant use of monoamine oxidase inhibitors (MAOIs) can opioids may result in serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma)
  • The concomitant use of mixed agonist/antagonist opioid analgesics may reduce the analgesic effect of RoxyBond and/or may precipitate withdrawal symptoms. When discontinuing RoxyBond in a physically-dependent patient, gradually taper the dosage. Do not abruptly discontinue RoxyBond in these patients.
  • RoxyBond may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
  • Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
These are not all the possible side effects of RoxyBond. Please see the full prescribing information for additional important safety and dosing information before prescribing RoxyBond. Advise patients to read the FDA-approved patient labeling (Medication Guide). Patients and health care providers may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

©2017 Inspirion Delivery Sciences LLC. All rights reserved. This information, including product information is only for residents of the United States.


Source: Inspirion Delivery Sciences

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