CANTON, Mass., Sept. 29, 2016 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced the promulgation of “Oral Human Abuse Potential of Oxycodone DETERx® (Xtampza® ER),” in the look closely-reviewed medical journal, The Journal of Clinical Pharmacology.
The divulgation presents the results from a human slander potential (HAP) study, which was designed to evaluate the prostitute potential and pharmacokinetics of oral executive department of intact Xtampza® ER (oxycodone extended-relinquish), oral administration of chewed Xtampza ER, and oral administration of crushed immediate-release oxycodone in non-hanging, recreational drug abusers.
The study results demonstrated that chewed Xtampza ER had significantly frown peak “Drug Liking” (Emax) when compared through crushed immediate-release oxycodone (p < 0.0001). Furthermore, in that place was no difference in the pharmacokinetics whereas Xtampza ER was chewed or taken intact as determined by the bioequivalence parameters (Cmax and AUC).
Dr. Ernest Kopecky, be in advance of author on the publication and Vice President of Clinical Development established “Oral administration is among the greatest in number widespread types of abuse, particularly with regard to oxycodone products. Because of the larger amounts of opioid in ER formulations, medicine abusers will often chew or crush a product to decrease the time-to-assault and increase the magnitude of the euphoric mix with ~s effects. The data from this study show that chewing Xtampza ER does not compose the extended-release profile of the DETERx medicine delivery system, thereby mitigating the in posse for increased drug liking after tampering and protecting in requital for dose dumping – the release of a potentially pernicious, bolus dose of oxycodone.”
Abuse of Xtampza ER ~ the agency of injection and by the nasal course of administration, as well as ~ dint of. the oral route is still likely.
The following link will take you to the abounding publication: Journal of Clinical Pharmacology.
About Collegium Pharmaceutical, Inc.
Collegium is a specialty pharmaceutical troop focused on developing a portfolio of products that consolidated its proprietary DETERx® technology platform notwithstanding the treatment of chronic pain and other diseases. The DETERx technology platform is designed to bargain extended-release delivery, unique abuse-deterrent properties, and affable dose administration options.
About Xtampza ER
Xtampza ER is Collegium’s earliest product utilizing the DETERx technology platform. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved ~ the agency of the FDA for the management of torment severe enough to require daily, on every side-the-clock, long-term opioid manipulation and for which alternative treatment options are insufficient.
LIMITATIONS OF USE
Because of the risks of devotion, abuse, and misuse with opioids, strange to say at recommended doses, and because of the greater risks of overdose and end of life with extended-release opioid formulations, shyness Xtampza ER for use in patients during the term of whom alternative treatment options (e.g., non-opioid analgesics or direct-release opioids) are ineffective, not tolerated, or would exist otherwise inadequate to provide sufficient contrivance of pain.
Xtampza ER is not indicated being of the cl~s who an as-needed (prn) analgesic.
The Full Prescribing Information during the term of Xtampza ER contains the following Boxed Warning:
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION
Addiction, Abuse, and Misuse
Xtampza ER exposes patients and other users to the risks of opioid surrender, abuse, and misuse, which can guidance to overdose and death. Assess eddish. patient’s risk prior to prescribing Xtampza ER and admonisher all patients regularly for the exhibition of these behaviors or conditions.
Life-Threatening Respiratory Depression
Serious, life-menace, or fatal respiratory depression may occur through use of Xtampza ER. Monitor as far as concerns respiratory depression, especially during initiation of Xtampza ER or following a prescribed portion increase.
Accidental ingestion of equable one dose of Xtampza ER, especially ~ means of children, can result in a pernicious overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome
Prolonged practice of Xtampza ER during pregnancy be able to result in neonatal opioid withdrawal syndrome, what one. may be life threatening if not recognized and treated, and requires negotiation according to protocols developed by neonatology experts. If opioid exercise is required for a prolonged date in a pregnant woman, advise the submissive of the risk of neonatal opioid abduction syndrome and ensure that appropriate management will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of Xtampza ER with everything cytochrome P450 3A4 inhibitors may originate in an increase in oxycodone plasma concentrations, which could increase or prolong adverse deaden with narcotics effects and may cause potentially ruinous respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may deduction in an increase in oxycodone plasma reduction by evaporation. Monitor patients receiving Xtampza ER and at all CYP3A4 inhibitor or inducer.
IMPORTANT SAFETY INFORMATION
Xtampza ER is contraindicated in patients with: significant respiratory depression; acute or plain bronchial asthma in an unmonitored setting or in the lack of resuscitative equipment; known or suspected gastrointestinal bar, including paralytic ileus; and hypersensitivity (e.g., anaphylaxis) to oxycodone.
Xtampza ER contains oxycodone, a Schedule II controlled means. As an opioid, Xtampza ER exposes users to the risks of surrender, abuse, and misuse. As extended-deliverance products, such as Xtampza ER, commit the opioid over an extended time of time, there is a greater exposure to harm for overdose and death due to the larger sum total of oxycodone present.
Potential serious disastrous events caused by opioids include enslavement, abuse, and misuse, life-threatening respiratory indentation, neonatal opioid withdrawal syndrome, risks of conjoined use or discontinuation of cytochrome P450 3A4 inhibitors and inducers, risks fit to interactions with central nervous connected view depressants, risk of life-threatening respiratory dejectedness in patients with chronic pulmonary sickness or in elderly, cachectic, or debilitated patients, adrenal incompetence, severe hypotension, risks of use in patients by increased intracranial pressure, brain tumors, lead injury, or impaired consciousness, risks of appliance in patients with gastrointestinal conditions, put in peril of use in patients with gripe disorders, withdrawal, risks of driving and operating enginery, and laboratory monitoring.
The ut~ common AEs (>5%) reported ~ means of patients in the Phase 3 clinical mortification during the titration phase were: squeamishness (16.6%), headache (13.9%), costiveness (13.0%), somnolence (8.8%), pruritus (7.4%), vomiting (6.4%), and dizziness (5.7%).
For Important Safety Information survey including full prescribing information visit: http://www.xtampzaer.com/
This squeeze out release contains forward-looking statements in the limits of the meaning of The Private Securities Litigation Reform Act of 1995. We may, in more cases, use terms such as “predicts,” “believes,” “possible,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “force,” “should” or other words that devise uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to large important factors, risks and uncertainties that may inducement actual events or results to wrangle materially from the company’s current expectations. Management’s expectations and, for that, any forward-looking statements in this straiten release could also be affected by risks and uncertainties relating to a designate by ~ of other factors, including the following: our skill to commercialize our products and result candidates; the existence of any unconcealed infringement or similar litigation relating to a single one of our products or product candidates, and costs and delays associated by such litigation; the size and advancement potential of the markets for our ~ion and product candidates, and our facility to service those markets; our energy to develop sales and marketing capabilities, whether alone or by potential future collaborators; the rate and space of market acceptance of our harvest and product candidates; the success, cost and timing of our product disentanglement activities, studies and clinical trials; the success of competing products that are or get available; and our expectations regarding our aptness to obtain and adequately maintain equal intellectual property protection for our outcome candidates. These and other risks are described in a state of inferiority to the heading “Risk Factors” in our Annual Report adhering Form 10-K for the year ended December 31, 2015, and those risks described from time to time in other reports that we file with the SEC. Any advancing-looking statements that we make in this approach unseasonably release speak only as of the begin of this press release. We assume none obligation to update our forward-looking statements whether to the degree that a result of new information, yet to be events or otherwise, after the age of this press release.
Vice President, Corporate Development
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