The company behind Narcan looks toward a treatment for fentanyl overdoses

Despite growing attention from lawmakers and doctors, the opioid crisis is not slowing up in the U.S. A new report published last week by the Centers for Disease Control and Prevention showed that emergency room visits for opioid overdoses jumped 30% in 45 states from 2016 to 2017.

The problem has morphed over the years – fentanyl, a powerful opioid that’s 30 times more potent than heroin, has grown in popularity among drug users, despite its deadly grip.

A nasal spray designed to reverse opioid overdoses called Narcan has become a life-saving tool used by police departments and communities around the country. Now, the company that created Narcan – Opiant Pharmaceuticals (NSDQ:OPNT) – is hoping that its latest drug-device combination can help people who are overdosing from fentanyl.

Get the full story at our sister site, Drug Delivery Business News.

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FDA clears shutdown of Lap-Band study for Apollo Endosurgery

Apollo Endosurgery (NSDQ:APEN) said late yesterday that the FDA approved the company’s move to terminate the Lap-Band lower body mass index post-approval study based on availability of long-term safety and effectiveness data on the device.

The trial was part of a bid for expanded indications, through which the FDA required the Austin, Texas-based company to conduct a prospective, multicenter, open-label, post-approval study to evaluate safety and effectiveness of the device in patients with BMIs between 30 and 39.9.

The study was slated to enroll 325 patients at 20 sites, with 181 subjects enrolled at 13 sites when it was terminated. Apollo said that with the early termination, it expects to save approximately $5.1 million, according to a press release.

Termination was approved based on the availability of long-term safety and effectiveness data on the Lap-Band in the lower BMI indications from existing published evidence. The company produced a final study report to the FDA which referenced 25 published studies exploring the use of the Lap-Band in lower BMI individuals.

Shares in Apollo Endosurgery have fallen 1.8% today, at $6.28 as of 10:34 a.m. EDT.

Earlier this month, Apollo Endosurgery saw shares fall after the medical device maker missed earnings per share expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings report.

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Humacyte closes $75m Series C round

Humacyte said today that it raised $75 million in a Series C preferred stock financing, led by a group of existing private investors and new investors.

The Research Triangle Park, N.C.-based company expects to use its newly-acquired funds to support an on-going Phase III pivotal study evaluating its human acellular vessel, Humacyl, as a conduit for hemodialysis in patients with end-stage renal disease who cannot have fistula placement.

Humacyte finished enrolling participants in the 350-patient trial last September and anticipates 12-month post-implantation data to be available in the third quarter of 2018.

The company also plans to use the funds to finish developing and testing the proprietary bioprocessing system planned to manufacture Humacyl.

The FDA granted Humacyl regenerative medicine advanced therapy designation in March last year, helping to speed the development and review of the device.

“The enthusiastic response from new and existing investors is a reflection of the remarkable opportunity Humacyte has to revolutionize vascular medicine, through our groundbreaking biomedical engineering platform,” chairman & CEO Carrie Cox said in prepared remarks. “Completing the final stage of clinical testing for our first product candidate later this year will be a significant achievement for our organization and the overall regenerative medicine industry.”

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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Cardiovascular Systems touts 18-month Liberty PAD study data

Cardiovascular Systems (NSDQ:CSII) today released 18-month results from the Liberty 360° study of peripheral artery disease interventions, touting high freedom from adverse events and amputations.

Results from the study were presented by Dr. William Gray of Wynnewood, Penn.’s Lankenau Heart Institute at the Cardiovascular Research Technologies 2018 interventional cardiology conference in Washington D.C., the St. Paul, Minn.-based company said.

“The 18-month Liberty 360° results continue to show that PVI, including the use of orbital atherectomy, can lead to amputation free survival for patients with claudication or critical limb ischemia,” CSI chair, prez & CEO Scott Ward said in a prepared statement.

In the study, researchers explored the use of endovascular device interventions for treating PAD, including those using Cardiovascular Systems orbital atherectomy system.

Data at 18 months indicated a continued 76.9% freedom from major adverse events in Rutherford Classifications 2-3, and 68.2% at Classifications 4-5. At RC 6, major adverse events were also not reportedly driven by major amputation, with a freedom from amputation rate of 81.7%

Quality of life improvements were significantly improved from baseline at 18 months across all arms in the trial, the company said.

In a sub-analysis, Dr. Gray noted that orbital atherectomy treatments had high freedom from major amputations across all Rutherford Classifications, with a 100% rate at RC2-3, 95.3% at RC 4-5 and 91.3% at RC6.

“Liberty 360° represents an unrestricted real-world experience with various endovascular strategies across different RCs, many of whom would never be included in clinical trials, especially, RC6 patients. The results we’ve seen in this novel, all-comers PAD study indicate that endovascular peripheral vascular intervention is a reasonable treatment option for RC2-3, RC4-5 and RC6,” Dr. Gray said in a prepared release.

Earlier this week, Cardiovascular Systems said that the FDA granted 510(k) clearance to the OrbusNeich‘s 1mm Sapphire II Pro coronary balloon, of which Cardiovascular Systems is the exclusie US distributor.

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Clearside Biomedical floats $75m public offering

Clearside Biomedical (NSDQ:CLSD) plans to offer $75 million in shares of its common stock in an underwritten public offering.

The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients with macular edema associated with non-infectious uveitis.

Get the full story at our sister site, Drug Delivery Business News.

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AJRR touts first-of-its-kind study on TJA revision rates

The American Joint Replacement Registry today released results from a study of total joint arthroplasty revision surgeries exploring the association between hospital size, reason for revision and where the surgery is performed.

The AJRR claims the study to be a first of its kind, with researchers exploring whether there is an association between hospital size and where the revision is performed, as well as how frequently Medicare patients returned to the same hospital or surgeon in the first year for joint infections or dislocations.

“Data on revision rates that depend exclusively on information from the same hospitals where the primary procedures are performed will under report the actual revision rates occurring,” lead study author Dr. Terence Gioe of the University of Minnesota Medical School said in a prepared statement.

Researchers examined hospital claims data and beneficiary enrollment data from Medicare, and found that in hospitals with over 150 beds, approximately 76% of revisions within one year were performed at the same hospital, with the rate increasing with hospital size.

For hospitals with over 450 beds, approximately 88% of revisions were performed at the same location, according to the study.

Infection-related revisions within the first year mainly occurred at the same hospital, with 83% sticking with the original hospital and 80% being performed by the same institution. For dislocation-related total hip arthroplasty revisions, 87% were reported to be performed in the same hospital, with 83% performed by the same surgeon.

“Although this study looked at Medicare data as opposed to AJRR data, the findings will inform future Registry research projects and will lay the groundwork as the AJRR becomes more diverse and comprehensive. It will be interesting to share the results of the study with our international counterparts, and to see if similar trends have occurred on a global scale,” AJRR analytics director Caryn Etkin said in a press release.

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Adamis Pharma’s EpiPen alternative succeeds in human factors study

Adamis Pharmaceuticals (NSDQ:ADMP) has positioned its emergency allergy treatment as a cheaper alternative to Mylan‘s (NSDQ:MYL) EpiPen device. The company has also set out to prove that its epinephrine injector is easy to use, even by people using an auto-injector for the first time.

Data from a human factors study conducted by Adamis were presented this week at a meeting of the American Academy of Allergy, Asthma and Immunology. The study found that participants could learn how to successfully use Adamis’ Symjepi device, which was approved by the FDA in June last year.

Get the full story at our sister site, Drug Delivery Business News.

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Clearside Biomedical enrolls first patient in Ph3 macular edema trial

Clearside Biomedical (NSDQ:CLSD) has enrolled the first patient in a Phase III trial evaluating its eye drug combined with an intravitreally-administered anti-VEGF agent as a treatment for macular edema associated with retinal vein occlusion.

The company’s drug, CLS-TA, is a proprietary suspension of triamcinolone acetonide designed to be administered in the space located between the choroid and the sclera.

Get the full story at our sister site, Drug Delivery Business News.

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Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues


Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio.

Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report.

A single patient was reported to have experienced a complication caused by a battery malfunction, which culminated in a battery advisory that was sent to doctors and the redevelopment of battery components, Healio reports.

A total of 33 patients were followed for up to 38 months in the Leadless trial, with a single patient unable to receive the Nanostim device due to a problem.

Survival at three years was reported at 74%, with no deaths reported as being related to the device, according to the report.

The rate of freedom from serious adverse events was reported at 89.9% at 40 months, with three patients experiencing device-related complications, according to Healio.

One patient had a reported procedure-related perforation leading to cardiac tamponade, another had an inadvertent placement of the device through a patent foramen oval leading to removal and re-implantation, while the last had a battery malfunction at 37 months that caused loss of communication, with the device being removed and replaced, according to the report.

No incidents of late device dislodgements, device infections or pacemaker syndrome were reported, and at three years electrical performance of the device was reported as being adequate, Healio reports.

“The overall [leadless cardiac pacemaker] complication rate of 10.1% is comparable to previous reports of transvenous pacemaker complications. Development of a new battery should resolve [the battery malfunction] issue. The adequate performance and freedom from [serious adverse device effects] at midterm follow-up in this first-in-humans patient cohort support the use of leadless pacing as an alternative to transvenous pacing, especially considering the promise of decreasing long-term pacemaker complications,” study author Dr. Fleur Tjong of Amsterdam’s AMC Heart Center said, according to the report.