Cara Therapeutics Announces Positive Results Of Peripheral Opioid; POZEN Appoints Senior VP and Chief Business Officer Print E-mail
By William Kent   
Wednesday, 29 October 2014 19:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 29, 2014. Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain without eliciting typical opioid (narcotic) side effects, announced positive results from its Human Abuse Liability (HAL) trial of an intravenous (I.V.) formulation of CR845, a first-in-class peripherally-selective kappa opioid agonist.

"We are extremely pleased with the results from this human abuse liability trial, which suggest the potential for CR845 to be the first Schedule V or non-scheduled peripheral opioid for acute pain," said Derek Chalmers, Ph.D, D.Sc., President and Chief Executive Officer of Cara Therapeutics. "The results are especially encouraging because CR845 was administered by rapid intravenous injection, which provides the fastest delivery of the highest level of drug into the bloodstream, a critical determinant of abuse liability. With positive analgesic efficacy data from two previous Phase 2 trials of I.V. CR845 and these positive HAL results now in hand, we look forward to advancing I.V. CR845 into Phase 3 clinical trials in early 2015."

Top-line results showed that therapeutic and supratherapeutic doses of I.V. CR845 met the trial's primary endpoint by demonstrating highly statistically significant lower "drug liking" scores as measured by visual analog scale (VAS) Emax (p <0.0001) when compared to I.V. pentazocine, a Schedule IV opioid receptor agonist. I.V. CR845 also demonstrated highly statistically significant lower "feeling high" and "overall liking" scores (p <0.0001) as compared to pentazocine. Additionally, both doses of I.V. CR845 were rated equivalent to placebo on "overall drug liking" and "take drug again" measures. "Drug liking," "feeling high," "overall liking" and "take drug again" scores are standard subjective measures recommended by the U.S. Food and Drug Administration (FDA) to assess a drug's abuse liability, both for recommended scheduling as well as labeling.

"Given the results seen in the HAL trial and in the Phase 2 trials conducted to date, I.V. CR845 has the potential to offer a new and safer approach to the treatment of acute pain," said Lynn Webster, M.D., lead investigator for the HAL trial at PRA Health Sciences and immediate past president of the American Academy of Pain Medicine. "CR845 differs from other opioids because it works on kappa opioid receptors that are localized on peripheral nerve endings. As such, CR845 doesn't enter patients' brains and doesn't cause side effects, such as euphoria, respiratory depression, nausea and vomiting that are common with existing opioids. The data accumulated to date suggest that CR845 could be a significant new development in pain management."

According to The Centers for Disease Control and Prevention (CDC), 46 people die each day in the U.S. from an overdose of prescription pain medications. Statistics compiled by the National Institute on Drug Abuse (NIDA) indicate that young adults (age 18 to 25) are the biggest abusers of prescription opioid pain relievers. In 2010, almost 3,000 young adults died from prescription drug (mainly opioid) overdoses—more than died from overdoses of any other drug, including heroin and cocaine combined—and many more needed emergency treatment. The total cost of prescription opioid abuse to the U.S. was $55.7 billion in 2007.

"One of the biggest challenges we face in providing optimal pain care is that many of our most effective medications have such high abuse potential," said Bob Twillman, Ph.D., Deputy Executive Director and Director of Policy and Advocacy for the American Academy of Pain Management. "An opioid analgesic that appears to reduce abuse potential to this extent is truly unprecedented. I am very hopeful that this means we will soon be able to substantially reduce the burden of pain experienced by patients without exposing them to significant risk of developing a substance abuse problem."



 
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POZEN Inc. (NASDAQ: POZN)
, a pharmaceutical company committed to transforming medicine that transforms lives, announced the promotion of Dennis McNamara to Senior Vice President and Chief Business Officer. Mr. McNamara is responsible for leading corporate development, alliance management and intellectual property efforts at POZEN. Prior to this appointment, Mr. McNamara held the position of Vice President, Business Development at POZEN, where he has been instrumental in successfully licensing POZEN’s products and product candidates to major pharmaceutical companies, including GlaxoSmithKline, AstraZeneca AB, sanofi-aventis U.S. LLC, Horizon Pharma US, Inc., and Cilag GmbH International.

“The Board of Directors and I are pleased to appoint Dennis as Chief Business Officer,” said Dr. John Plachetka, Chairman, President and Chief Executive Officer of POZEN. “He has been an exceptional employee throughout the years and we look forward to working with Dennis in his new and expanded role.”


 


Also Wednesday:


 
Accuray Incorporated (Nasdaq:ARAY)
announced today financial results for the first fiscal quarter ended September 30, 2014.

Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today that it will showcase its new spinal fixation system, Arsenal as well as its comprehensive portfolio of products at the upcoming North American Spine Society (NASS) meeting at the Moscone Convention Center in San Francisco, California, which will be held from November 12th – 14th, 2014.

Amedisys, Inc. (Nasdaq:AMED)
, a leading home health and hospice company, today reported its financial results for the three and nine-month periods ended September 30, 2014.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that David Jackson, Ph.D., Vice President of Diagnostics & Companion Diagnostics, has been selected to present at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference, being held October 27-29, 2014 in Alexandria, Va.

Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of bone graft material and coatings for medical applications, today announced the release of two unique new products for use in spinal procedures, 3Demin™ Boats and 3Demin™ Strips.

Cempra, Inc. (Nasdaq:CEMP)
, a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today reported financial results for the quarter and nine months ended September 30, 2014 and provided an update on recent corporate developments.

Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, today announced it intends to embark on a nationwide search for a new Chief Executive Officer.

Endocyte, Inc., (Nasdaq:ECYT)
announced today that the company will host a conference call on Wednesday, Nov. 5, at 4:30 p.m. EST to discuss its third quarter 2014 financial results and provide an operational update.

Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX)
, a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that it will host a Key Opinion Leader breakfast on Tuesday, November 4, 2014 from 8:00am-9:30am Eastern Time in New York City.

Foundation Healthcare, Inc. (OTC Markets:FDNH)
, which focuses on the development and management of surgical hospitals and related ancillary services, announced today the Company's financial results for the third quarter which ended September 30, 2014.

Health Insurance Innovations, Inc., (Nasdaq:HIIQ)
, a leading developer and cloud-based administrator of affordable health insurance plans, ancillary products and research-driven consumer health insurance plan shopping tools is pleased to announce that a new independent director, Mr. Robert Murley, has been appointed to HII's Board of Directors, effective immediately.

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that isactuzumab govitecan (IMMU-132), the Company's proprietary solid-tumor antibody-drug conjugate (ADC), continues to produce encouraging results in a Phase 2 clinical trial in heavily-pretreated patients with diverse, metastatic solid cancers.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
today reported financial results for the three months ended September 30, 2014.

LDR Holding Corporation (Nasdaq:LDRH)
, a global medical device company focused on designing and commercializing novel and exclusive surgical technologies for the treatment of patients suffering from spine disorders, announced that JAMA Surgery, a peer-reviewed publication, has published a cost-effectiveness study of the two-level Mobi-C® Cervical Disc in comparison to two-level Anterior Cervical Discectomy & Fusion (ACDF).

LifeVantage Corporation (Nasdaq:LFVN)
announced today that it will release financial results for its first quarter ended September 30, 2014, after the market closes on Thursday, November 6, 2014.

Lombard Medical, Inc. (Nasdaq:EVAR)
, a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today reported operational progress and financial results for the third quarter and nine months ended September 30, 2014.

Matinas BioPharma Holdings, Inc. (OTCQB:MTNB)
, an emerging biopharmaceutical company focused on the development and commercialization of omega-3 fatty acid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions, today announced that it has received a Notice of Authorization from Health Canada to initiate the first-in-human study of MAT9001.

MedAssets, Inc. (Nasdaq:MDAS)
today announced results for its third quarter and nine-month period ended September 30, 2014.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced its financial and business results for the third quarter of 2014.

Myriad Genetics, Inc. (Nasdaq:MYGN)
announced today that Mark Capone, president of Myriad Genetics Laboratories, is scheduled to present at the 2014 Credit Suisse Annual Healthcare Conference, at 3:00 p.m. Eastern on November 12, 2014, at the Arizona Biltmore Hotel in Phoenix, Arizona.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax' H7N9 Virus-Like Particle Vaccine Candidate (H7N9 VLP) adjuvanted with Matrix-M™.

Recro Pharma, Inc. (Nasdaq:REPH)
, a clinical stage specialty pharmaceutical company developing non-opioid therapeutics for the treatment of pain, initially for acute pain following surgery, today announced dosing of the first patient in a Phase II clinical trial of Dex-IN in patients who initiate dosing of study medication on Post Op Day 1, following bunionectomy surgery.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, announced today that the Company will release third quarter 2014 financial results on Wednesday, November 12, 2014 after the close of market.

Sharps Compliance Corp. (Nasdaq:SMED)
, a leading full-service provider of solutions for the cost-effective management of medical waste, used healthcare materials and unused dispensed medications, today reported financial results for the first quarter of fiscal year 2015, ended September 30, 2014.

Nasdaq (Nasdaq:NDAQ)
announced that trading of Sientra Inc. (Nasdaq:SIEN), a medical aesthetics company, commenced on The Nasdaq Stock Market on October 29, 2014.

ReWalk Robotics Ltd. (Nasdaq:RWLK)
today announced that the Company will release its 2014 third quarter financial results on Thursday, November 13, 2014, before the U.S. financial markets open.

TriVascular Technologies, Inc. (Nasdaq:TRIV)
, manufacturer of the Ovation Prime® Abdominal Stent Graft System, today announced the Company will be participating in three upcoming investor conferences.

Vision-Sciences, Inc. (Nasdaq:VSCI)
, a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced that the Company will release its financial results for the second quarter fiscal 2015, ended September 30, 2014, after the market closes on Wednesday, November 5, 2014.



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