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Collegium completes Type A meeting with FDA for COL-003 Phase III chronic low back pain study

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced today that it has successfully completed a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed Phase III clinical study for COL-003, the Company's tamper-resistant, extended release oxycodone product utilizing its proprietary DETERx technology.

27 Sep 2011

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Butrans (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

26 Sep 2011

Too many kids poisoned with prescription drugs: Study

Figures show that each year half a million kids age 5 and younger get into household medications and are poisoned. Though parents tend to believe that these tragic accidents will never happen to their kids, Dr. Randall Bond, a leading advocate for better prescription drug safety in the home, believes it can happen to anyone.

19 Sep 2011

New study aims to reduce number of pediatric pharmaceutical poisoning

Pharmaceutical poisoning remains a common childhood injury, despite years of concerted prevention efforts, such as improved safe guards on packaging. Over half a million children are exposed to pharmaceuticals each year. A new study soon to be published in The Journal of Pediatrics attempts to understand this growing problem to aid in the progress of reducing the number of childhood injuries due to pharmaceutical poisoning.

16 Sep 2011

Oxycodone no safer than codeine for breastfed infants: New study

Doctors have been prescribing codeine for postpartum pain management for many years, and, until recently, it was considered safe to breastfeed while taking the opioid. But the death of an infant exposed to codeine through breast milk has many health care providers questioning the safety of the drug when used by breastfeeding mothers.

7 Sep 2011

Florida steps up efforts against pill mills; Hospital executives under scrutiny

The New York Times looks at Florida's efforts to stop illegal sales of prescription drugs while other outlets examine local hospital issues.

2 Sep 2011

Health Affairs report describes ground-breaking effort that aims to prevent opioid abuse

Fatal overdoses involving prescribed opioids tripled in the United States between 1999 and 2006, climbing to almost 14,000 deaths annually-more than cocaine and heroin overdoses combined. Hospitalizations and emergency room visits related to prescription opioid pain medicines such as oxycodone and hydrocodone also increased dramatically in the same period.

5 Aug 2011

FDA approves Covidien's morphine sulfate oral solution for chronic pain in opioid-tolerant patients

Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) recently granted approval to the company's Mallinckrodt business for morphine sulfate oral solution, used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients. The solution will be available as a generic in 100 milligrams per 5 mL (20 milligrams per 1 mL).

1 Aug 2011

BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

BioDelivery Sciences International, Inc. announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain, signifying completion of the trial.

25 Jul 2011

Study explores factors for misuse of prescription opioid in young injection drug users

A new study by researchers at Drexel University's School of Public Health suggests that abuse of prescription painkillers may be an important gateway to the use of injected drugs such as heroin, among people with a history of using both types of drugs.

25 Jul 2011

FDA approves Cephalon's REMS for FENTORA, ACTIQ

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA and ACTIQ.

22 Jul 2011

Novel vaccine for treating heroin addiction

Researchers at The Scripps Research Institute have developed a highly successful vaccine against a heroin high and have proven its therapeutic potential in animal models.

21 Jul 2011

QRxPharma seeks NDA approval for MoxDuo IR

QRxPharma Limited announced today initiation of the New Drug Application (NDA) approval process for MoxDuo IR with the United States Food and Drug Administration (FDA). This NDA submission sets the stage for the regulatory approval process for MoxDuo IR for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US.

18 Jul 2011

Obama administration turns bright spotlight on prescription painkiller abuse

The Obama administration turned a bright spotlight on prescription painkiller abuse in April when the Office of National Drug Control Policy released a national action plan and a statement from Vice President Joe Biden.

2 Jul 2011

Endo recalls two lots of Endocet Tablets

Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV.

27 Jun 2011

FDA issues Complete Response Letter for Pfizer's REMOXY NDA

DURECT Corporation today reported that Pfizer Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY, a controlled-release form of oxycodone designed to discourage common methods of tampering.

27 Jun 2011

Pfizer and Pain Therapeutics receive FDA Complete Response Letter for resubmission of REMOXY NDA

Pfizer and Pain Therapeutics, Inc. announced that a Complete Response Letter was received from the U.S. Food and Drug Administration (FDA) on the resubmission to the new drug application (NDA) for REMOXY® (oxycodone) Extended-Release Capsules CII. Pfizer is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them.

24 Jun 2011