Lyndra to develop ultra-long-acting opioid use disorder therapy

lyndra-therapeutics-logoLyndra Therapeutics (Watertown, Mass.) announced that it is developing an ultra-long-acting oral treatment for opioid use disorder.

On average, about 130 Americans die every day from an opioid overdose, according to the Centers for Disease Control and Prevention. Lyndra Therapeutics received a grant from the National Institutes of Health to help find new treatment strategies and formulations of existing medications to address the opioid epidemic.

The grant covers the development of a once-a-week oral dosage of buprenorphine, which is a medication-assisted treatment that has shown to have improved outcomes for patients with opioid use disorder.

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

Medtronic touts new targeted drug delivery study results

Medtronic logo updatedTargeted drug delivery and conventional medical management have shown to have a reduction in healthcare use and costs for cancer patients in comparison to conventional medical management alone, according to a new study from Medtronic.

The study found that there were significant cost savings to payers and fewer inpatient visits with shorter inpatient stays. It also showed that there were fewer emergency department visits for people who used targeted drug delivery (TDD) and conventional medical management (CMM).

Medtronic suggests that TDD therapy had a significant average overall cost savings of $63,498 with fewer opioid prescriptions per patient. The company says that TDD, when delivered through Medtronic’s SynchroMed II Infusion System, could be an alternative to oral opioids.

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

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Avanos Medical wins FDA nod for ON-Q Bolus pump

Avanos

Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device.

The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management.

Read the whole story on our sister site, Drug Delivery Business News

Dyve Bioscience touts proof-of-concept study for transdermal painkiller

Dyve Bioscience logoDyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare.

The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the placebo group were given lotion without sodium bicarbonate or menthol. Investigators told the participants to report to the clinic within 36 hours of flare onset.

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

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Theranica raises $35m Series B for neuromod migraine patch

TheranicaTheranica Bio-Electronics said yesterday that it raised a $35 million Series B round for the Nerivio Migra neurostim patch it’s developing to treat migraine headache.

Netanya, Israel-based Theranica said VC shop aMoon led the round, joined by all of its existing backers, Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company raised an unspecified amount in its seed round back in September 2016.

Theranica closed out a nearly 300-patient pivotal study last October it used to back a bid for FDA clearance that met its primary endpoint and showed “high efficacy, safety and tolerability.”

“The new funds will allow the company to mass-produce the Nerivio Migra and – once cleared by the FDA – to deliver the device to millions of migraine patients in the USA,” co-founder & CEO Alon Ironi said in prepared remarks. “They will also enable further development, targeting additional clinical syndromes. We chose to start with the USA because this is the largest single market for migraine and headache and because we were highly impressed by the readiness of the American medical community to apply drug-free, non-addictive solutions for headache and other types of pain.”

“Theranica’s vision and current stage align well with the investment strategy of our late stage fund,” added aMood partner Todd Sone. “Theranica’s innovative migraine device combines excellent clinical efficacy, safety and tolerability, together with advanced digital technologies to maximize the benefit for patients.”

“This new partnership with aMoon, together with the on-going support from our existing investors, gives Theranica the fuel to commercialize the product, bring it to the masses and ultimately improve migraine therapy worldwide, by turning this innovative, non-invasive, drug-free solution into the first line of treatment,” co-founder & chairman Dr. Shimon Eckhouse said.

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Pacira to acquire Myoscience in $220m deal

Pacira PharmaceuticalsPacira Pharmaceuticals (NSDQ:PCRX) said today that it has signed a deal to acquire Myoscience and its pain relief device for up to $220 million.

Myoscience’s iovera system is designed to safely freeze nerves while protecting surrounding tissue. As part of the deal that is slated to close by early April, Pacira plans to incorporate the iovera system into its non-opioid product portfolio.

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

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Teva launches generic for Pfizer’s Flector pain patch

Teva updated logoTeva (NYSE:TEVA) said last week that it launched a generic version of Pfizer‘s (NYSE:PFE) Flector diclofenac epolamine patch.

Using a nonsteroidal anti-inflammatory drug, the topical patch is designed to treat acute pain due to minor strains, sprains and contusions.

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

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How NeuroMetrix seeks to better relieve pain with AI

NeuroMetrix Quell 2.0 AI artificial intelligence pain relief

NeuroMetrix’s Quell 2.0 [Image courtesy of NeuroMetrix]

NeuroMetrix plans to add artificial intelligence to the latest iteration of its Quell transcutaneous electrical nerve stimulation (TENS) device.

AI will allow Quell 2.0 to tailor treatment to each individual user, according to the Waltham, Mass.–based based company.

Launched in September 2018 Quell 2.0 is 50% smaller and 20% more powerful than the original Quell, which debuted in 2015. Quell is worn on the leg regardless of the site of pain and is designed to send neural pulses to the brain that trigger a natural pain relief response in the central nervous system. Patients control the device and track their pain using a smartphone app. Quell 2.0 is available over-the-counter for about $300.

So how could AI help patients who use the device? NeuroMetrix chief commercial officer Frank McGillin recently discussed the decision to use AI and the future of Quell with our sister site Medical Design & Outsourcing.

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FDA clears Medtronic Accurian RF nerve ablation device

Medtronic logo updatedMedtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its Accurian radiofrequency nerve ablation device for treating chronic pain.

“Medtronic has a long-established track record of bringing to market improved options to support clinicians with state-of-the-art technology, like the Accurian RF ablation system, which was designed for consistency and efficiency,” pain therapies president Dr. Marshall Stanton said in prepared remarks. “Medtronic is committed to advancing the treatment of pain as we introduce new options to help patients throughout the care continuum.”

“The Accurian RF ablation platform is a significant addition in my practice because I know I’ll get the same lesion every time in every channel due to how responsive the generator is in managing power and temperature,” added Dr. Leo Kapural of Winston-Salem’s Carolinas Pain Institute & Center for Clinical Research. “RF ablation requires both precision and flexibility. Accurian is intuitive and easy to use and enables me to easily upgrade the system and perform enhanced lesions with cooled RF probes.”

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Relievant back-pain device study stopped for positive results

Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management.

The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The trial’s independent data management committee recommended that investigators stop enrollment and offer Intracept treatment to control-arm patients, according to the Minneapolis, Minn.-based company.

The interim analysis of the primary endpoint 104-participant trial demonstrated a 20.9 point difference in mean ODI reduction at three months between the Intracept arm and the non-surgical management arm. The Intracept-treated patients reported a 25.3 point reduction in ODI from baseline at three months. One-year results from a prior study released in February 2018 showed a statistically significant difference between patients treated with Intracept and a sham treatment cohort.

“This is the second Level I study that has demonstrated clinically significant improvement in pain and function for patients with modic changes on MRI and solidifies the Intracept procedure as a compelling early treatment option for patients with (chronic lower back pain),” said principal investigator Steven Garfin, M.D., interim dean, University of California San Diego School of Medicine, in a prepared statement.

“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Relievant Medsystems CEO Kevin Hykes. “The Intracept procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept procedure.”

The full results of the Intraceptstudy are expected to be presented and published later in 2019.

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