News

Teva advances development of abuse-deterrent hydrocodone bitartrate extended-release tablets

BY Michael Johnsen

JERUSALEM – Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission to the Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology, providing potential abuse-deterrent properties (CEP-33237) as allowed for fast-track designated products. Teva expects to complete the NDA submission by the end of 2014. 
 
CEP-33237 is an investigational, 12-hour, acetaminophen-free formulation of extended-release hydrocodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.
 
Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone.
 
“Teva understands the risk of opioid abuse is a societal challenge and one many healthcare professionals face in treating people living with chronic pain,” said Michael Hayden, president of global R&D and chief scientific officer at Teva. “While the science of abuse deterrence is rapidly evolving, we are pleased with the results of our HAL studies and the comprehensive clinical program that supports the NDA for CEP-33237.”
 
 
Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal.
 
In the intranasal HAL study, abuse potential was significantly lower for crushed intranasal CEP-33237 (45 mg) than for intranasal IR hydrocodone powder (45 mg) based on peak at-the-moment drug liking and peak overall drug liking.
 
In the oral HAL study, abuse potential was significantly lower for crushed CEP-33237 (45 mg) powder than for IR hydrocodone (45 mg) based on peak at-the-moment drug liking. Overall drug liking was also significantly lower for crushed CEP-33237 compared to IR hydrocodone.
 
In both studies, intact CEP-33237 showed similar abuse potential to placebo.
 
“The comprehensive clinical program supporting CEP-33237 is an example of Teva’s long-term commitment to advancing responsible pain care,” said Richard Malamut, VP global clinical development and therapeutic area head of pain at Teva. “While no product or technology can completely eliminate abuse, having both positive oral and nasal HAL data speaks to the potential of CEP-33237 as a chronic pain treatment option with abuse deterrence properties.”
 
Topline results from the CEP-33237 pivotal Phase III study announced on April 30, 2014 showed significant improvement in the treatment of patients’ chronic low back pain as measured by both weekly Average Worst Pain Intensity and weekly Average Pain Intensity scores. The full results from the Phase III trial will be presented at the 15th World Congress on Pain hosted by The International Association for the Study of Pain in Buenos Aires, October 6 to11.
 
CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence and dizziness.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

News

CRN convenes a keynote panel in celebration of the 20th anniversary of DSHEA at annual meeting

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition on Wednesday announced it will convene a keynote panel of legal, regulatory and legislative experts in celebration of the 20th anniversary of the Dietary Supplement Health and Education Act of 1994 at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry, Nov. 5 to 8.
 
The three panelists, all of whom were there for the birth of DSHEA, were among those who helped create, marshal and pass the landmark legislation that the industry has lived under for the past 20 years. This session will reunite these key players who will share their personal anecdotes and assessments about how and why DSHEA came about, and whether it’s still the appropriate law for the industry.  
 
Scott Bass, partner, Sidley Austin, will deliver the keynote address. Bass played a key role in shaping DSHEA as an industry representative with what was then the National Nutritional Foods Association. Following his remarks, Patricia Knight, strategic partner, Knight Capitol Consultants and Kay Holcombe, SVP science policy, BIO, the Biotechnology Industry Organization, will take the stage along with him as panelists. In 1994, and for many years before and after, Knight was an integral leader in the office of Sen. Orrin Hatch, D-Utah — a longtime industry champion, and one of the architects responsible for creating and passing DSHEA. Holcombe served as professional health legislative staff and senior health policy advisor to the Energy and Commerce Committee in the House of Representatives under Rep. John Dingell, D-Mich., and was instrumental in developing the bill and building consensus in the House.
 
“We are excited to hear from these three policy veterans who were so important 20 years ago to DSHEA’s passage into law,” stated Mike Greene, VP government relations, CRN. “There were so many people involved in DSHEA’s passage, but Scott, Trisha and Kay possess a unique perspective, having remained active in the dietary supplement and regulatory arena since that time. We trust they will provide interesting historical notes on the law that still shapes our business today, as well as counsel on the future of DSHEA and the dietary supplement industry.”
 
The “DSHEA at 20” session will take place the morning of Thursday, Nov. 6. In addition to the Conference, CRN is presenting The Workshop: CRN’s Day of Science, an all-day symposium on Nov. 5, just prior to The Conference. 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

News

PhRMA: Cancer drug ‘failures’ are a critical part of the drug development process

BY Michael Johnsen

WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Tuesday released a new report, “Researching Cancer Medicines: Setbacks and Stepping Stones,”  which highlights the number of investigational cancer medicines that did not succeed in clinical trials and how these “failures” are a critical part of the drug development process. 

The report illustrates the immense challenges in bringing new medicines to patients with cancer, and explores the factors that contributed to both the approvals of new treatments and those that “failed” between 1998 and 2014. The report focuses on three cancers that are particularly difficult to treat: melanoma, lung cancer and brain cancer.
 
Findings include:
 
  • 96 potential treatments for melanoma did not make it through clinical trials, but paved the way for 7 approved medicines, a nearly 14:1 ratio of “failures” to “successes”;
  • 10 medicines have been approved to treat lung cancer, whereas 167 other potential treatments did not make it through clinical trials; and
  • Only 3 new medicines have been approved to treat brain cancer, while another 75 investigational medicines were unsuccessful in the development process.
 
Despite these challenges, America’s biopharmaceutical companies continue to invest in research to develop new treatments. According to a new report by PhRMA, there are nearly 800 cancer medicines and vaccines either in clinical trials or awaiting review by the Food and Drug Administration. Of these medicines, more than 50 are for the treatment of melanoma, 98 for lung cancer and 47 for brain cancer.
 
“While it may sound counterintuitive, research setbacks are instrumental to furthering efforts to better understand a disease and how to treat it. They are also an indication of the incredible difficulty in developing medicines to treat cancer,” stated John Castellani, PhRMA president and CEO. “These setbacks serve as a reminder that to make progress, we need a public policy framework that supports drug development in combination with promising science so that we can bring important innovations to patients.”
 
Significant advancements in the treatment of diseases like cancer are typically the result of cumulative innovation over time, rather than a single breakthrough in treatment. Every success — and every “failure” — builds on previous advances to improve patients’ lives. Research has shown that cancer is actually a set of more than 200 extremely complex diseases and discovering medicines that effectively treat each one is a difficult task.
 
“While it is incredibly disappointing to see a promising new drug candidate eliminated from the pipeline, researchers take immeasurable learnings from every setback and build upon each one to develop effective therapies for patients,” said Castellani.
 
The release of the “Researching Cancer Medicines: Setbacks and Stepping Stones,” report comes in advance of the Turning the Tide Against Cancer National Conference on Oct. 9. At the meeting, Castellani will join other health care stakeholders to discuss ways to improve cancer care and promote innovation. 

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES