Orexo AB (ORXOY: OTCQX International) | Orexo Features Positive Results from the ISTART Study at the 2014 AAAP Meeting

MORRISTOWN, N.J., Dec. 6, 2014 /PRNewswire/ — Orexo US, Inc. (Orexo) announced results from the ISTART/006 study, being presented today at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry (AAAP) in Aventura, Florida, USA. In the study, ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) demonstrated comparable patient retention in treatment at day 15 versus Suboxone® film. ZUBSOLV also demonstrated no increased rate of withdrawal symptoms or opioid cravings versus Suboxone film at day 15 and day 22. AAAP marks the first time these data are presented in a peer-reviewed forum, following the release of topline results in June 2014.

“We look forward to unveil these findings of the ISTART/006 study – the largest clinical trial ever conducted in the United States to assess buprenorphine/naloxone for the treatment of opioid dependence – reinforcing our dedication to advance research in leveraging medication-assisted treatment for opioid dependence,” said Michael Sumner, M.D., Chief Medical Officer, Orexo US, Inc. “Despite an average 26 to 32 percent lower dose of buprenorphine in ZUBSOLV compared to that in Suboxone film used, ZUBSOLV showed comparable efficacy to Suboxone film, which may help reduce the potential for misuse.”

ISTART Study Design Outcomes

The ISTART study was a randomized, multicenter, non-inferiority Phase 3 clinical trial designed to evaluate the efficacy of ZUBSOLV compared with Suboxone film during stabilization of patients with opioid dependence.

758 patients began the maintenance phase of the study with either ZUBSOLV or Suboxone film.  At day 15, ZUBSOLV patients switched to Suboxone film and those taking Suboxone film switched to ZUBSOLV.

The co-primary endpoint was retention in treatment at day 15. On day 15, the number of patients who were retained in treatment were similar across the ZUBSOLV and Suboxone film arms (74.9 percent versus 74.4 percent, respectively, P=0.866).

Secondary endpoints included assessment of treatment effects on opioid withdrawal symptoms for ZUBSOLV versus Suboxone film via both the Clinical Opiate Withdrawal Scale (COWS) score and Subjective Opiate Withdrawal Scale (SOWS), and opioid cravings via the visual analogue scale (VAS). Reductions in opioid withdrawals and opioid cravings were comparable between treatment groups.

The safety profile of ZUBSOLV was similar to that of Suboxone film.  

“I am pleased to present the data of the ISTART study at AAAP, demonstrating ZUBSOLV is comparable to Suboxone film to treat opioid dependence,” said Erik Gunderson, M.D., FASAM, Assistant Professor in the Department of Psychiatry and Neurobehavioral Sciences and Department of Medicine at the University of Virginia, and principle investigator of the study.

Robert DeLuca R.Ph., President of Orexo US, Inc. noted, “The ISTART/006 data and our presentation at AAAP are another example of Orexo’s continued commitment to both advancing the treatment of opioid dependence and supporting the patients who suffer from this disease as well as the healthcare professionals who treat them.”

For further information contact:
Robert DeLuca, President, Orexo US, Inc.
Telephone: 1-973-936-6990

For a visual backgrounder on the ISTART/006 study, visit: http://origin-qps.onstreammedia.com/origin/multivu_archive/ENR/ZUBSOLV_One-Pager.pdf



ZUBSOLV Packaging


ZUBSOLV (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

ZUBSOLV sublingual tablets can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential. Liver function tests should be monitored before and during treatment. Children who take ZUBSOLV sublingual tablets can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep ZUBSOLV sublingual tablets out of the sight and reach of children.

Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.

Further information on ZUBSOLV can be found at www.zubsolv.com.

Important Safety Information

  • Keep ZUBSOLV in a secure place away from children. If a child accidentally takes ZUBSOLV, this is a medical emergency and can result in death. Get emergency help right away
  • ZUBSOLV can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if (a) you feel faint, dizzy, or confused; (b) your breathing gets much slower than is normal for you; (c) you feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes and breathing. In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with ZUBSOLV
  • The most common side effects of ZUBSOLV include: headache, drug withdrawal syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased sweating, swelling of the extremities, and constipation. Tell your doctor about any side effect that bothers you or that does not go away
  • Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of ZUBSOLV is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine that may be different than other buprenorphine-containing medicines you may have been taking
  • ZUBSOLV contains an opioid that can cause physical dependence. Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine. Physical dependence is not the same as drug addiction. ZUBSOLV is not for occasional or “as needed” use
  • An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your doctor what you should do if you are taking one of these. You should not drink alcohol while taking ZUBSOLV, as this can lead to loss of consciousness or even death
  • Do not inject (“shoot-up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems. Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings
  • Before taking ZUBSOLV, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
  • Before taking ZUBSOLV, tell your doctor if you are pregnant or plan to become pregnant. It is not known if ZUBSOLV will harm your unborn baby. If you take ZUBSOLV while pregnant, your baby may have symptoms of withdrawal at birth. Talk to your doctor if you are pregnant or plan to become pregnant
  • Before taking ZUBSOLV, tell your doctor if you are breastfeeding or plan to breastfeed. ZUBSOLV can pass into your breast milk and may harm the baby. Talk to your doctor about the best way to feed your baby if you take ZUBSOLV. Monitor your baby for increased sleepiness and breathing problems
  • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take ZUBSOLV
  • ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law
  • To report negative side effects associated with taking ZUBSOLV, please call 1-888-982-7658. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Please see full Prescribing Information and Medication Guide for ZUBSOLV.

Suboxone is a registered trademark of Reckitt Benckiser (UK) Ltd.

About Orexo US, Inc.

Orexo US, Inc. is an emerging specialty pharmaceutical company marketing improved treatments for opioid dependence using proprietary drug delivery technology. To receive more information please contact Orexo at 1-888-ZUBSOLV.

About Orexo AB

Orexo AB is a specialty pharma company with commercial operations in the United States and RD in Sweden developing improved treatments using proprietary drug delivery technology and commercial operations in the United States. The company is commercializing its proprietary product, Zubsolv®, for maintenance treatment of opioid dependence, in the United States. Zubsolv is a novel formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Orexo has a portfolio of two approved and revenue generating products currently marketed under license in the EU and US. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ OMX Stockholm Exchange and its American Depositary Receipts (ADRs) trade on the OTCQX marketplace in the U.S. under the symbol, “ORXOY”. The largest shareholders are Novo A/S and HealthCap.

For information about Orexo, please visit www.orexo.com.

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SOURCE Orexo US, Inc.

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