Hollywog unveils smartphone-controlled pain device

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As revealed by our recently published MAT Q2 2017 info, global sales of topical analgesics (+8.2%) fast outpaced systemic analgesics (+3.8%), owing to higher levels of product innovation. This trend was particularly noticeable in North America, where sales of topical analgesics were up 16.2% in the year to end-June 2017.

One specific area of dynamism has been topical pain relief devices, specifically TENS machines, with a variety of smaller marketers and established OTC players launching such products in recent years. For example, Bayer launched TENS device Aleve Direct Therapy in summer 2016.

The innovation stakes have now been raised higher with the launch of a smartphone-controlled TENS device by US marketer Hollywog. The WiTouch Pro Bluetooth TENS Therapy device is paired with the WiTouch Pro App to provide stimulation pain therapy to the lower back.

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According to Chuck Thomas, CEO of Hollywog: “This launch signals an important innovation for Hollywog, where our new patented pain management solution, the WiTouch Pro, offers a drug-free digitally-enabled alternative to block pain and keep moving. People are looking for a discrete solution that is personalised for their pain and with this launch we deliver on that need.”

This trend is likely to accelerate, with marketers like Purdue Pharma already looking at how to deliver pain therapy via smartwatches too.

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Voice-activated tech shows potential for diabetes care

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Diabetes affects 422mn people worldwide, including 14% of the US adult population and people in low and middle-income countries such as China, India, Brazil and Indonesia. To successfully manage diabetes, people living with it need to be mindful of and track myriad things throughout their day, from blood sugar levels to counting calories. In recent years voice-activated technologies have become an important way of helping sufferers manage their disease.

In this regard, Danish pharmaceutical company, Novo Nordisk, has teamed up with Health Innovation Technology Lab (HITLAB) to launch the 2017 HITLAB World Cup of Voice-Activated Technology in Diabetes, awarding prizes totalling US$75,000.

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Participating innovators have been told to focus on enhancing patient outcomes, lowering healthcare costs and making the management of patients more efficient, with the goal of improving health and quality of life for diabetes sufferers.

Amy West, Senior Director, Patient Centric Marketing & Digital Health at Novo Nordisk commented: “We are constantly striving to provide solutions that minimise the burden for people living with diabetes, and believe that digital health, and specifically voice-activated technologies can be important tools for managing diabetes.”

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HITLAB has helped leading organisations create and evaluate technology-based solutions to pressing healthcare challenges for the past 25 years. Last year, 74 teams from 14 countries presented technology innovations that ranged from a tech-enabled dynamic scoliosis brace to a tool that uses 3D imaging and data analytics to better diagnose ear infections. Past winners have since raised over US$50mn in follow-on investment funding.

The submission period is currently open and will close on Wednesday 11th October. Finalists will be announced on 23rd October. They will make pitches at the HITLAB Innovators Summit, which will be held in New York City. Pitches will be judged by a panel of healthcare experts assigned by Novo Nordisk and HITLAB.

FDA permits marketing of first mobile medical app

USA’s Food & Drug Administration has permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). It is planned that the reSET application, to be marketed by Pear Therapeutics, will be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs but will not treat opioid dependence.

The reSET device was reviewed through the de novo premarket review pathway, a regulatory pathway for some low to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

Carlos Peña, Director of the Division of Neurological & Physical Medicine Devices at the FDA’s Centre for Devices & Radiological Health commented: “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment.” Peña continued, “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.”

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The reSET device is a mobile medical app containing a patient application and clinician dashboard. The device delivers cognitive behavioural therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programmes.

The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of reSET which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used reSET (40.3%) compared to the patients who did not (17.6%).

The reSET device is indicated as a prescription-only adjunct treatment for patients with SUD who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or whose primary substance of abuse is not opioids.

Belfast scientists say aspirin could reverse tooth decay

Aspirin has long been prized for its painkilling properties, while low-dose aspirin is a popular systemic cardiovascular treatment, but new research shows that it could also reverse tooth decay.

According to a BBC report, the effects of tooth decay could potentially be reversed by the use of aspirin and lead to fewer fillings being needed in the future, researchers in Belfast have said. Tooth decay, the most common dental disease, leads to the inflammation of the tooth nerve, causing toothache.

Initial research at Queen’s University found aspirin stimulates stem cells in teeth, enhancing tooth regeneration. Current treatment for tooth decay involves fillings, which may need to be replaced many times during the lifetime of the tooth.

The British Dental Association reported in 2016 that 72% of 15-year-olds in Northern Ireland have dental decay. That figure compared to 44% in England and 63% in Wales.

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Teeth naturally have limited regenerative abilities. They can produce a thin band of dentine, the layer just below the enamel, if the inner dental pulp becomes exposed, but this cannot repair a large cavity.

The research findings, to be presented later this week at the British Society for Oral and Dental Research annual conference, show that aspirin can enhance the function of those stem cells, thus helping self-repair by regenerating lost tooth structure.

The researchers collated large amounts of previous research data to identify aspirin as a compound that can induce the gene signature needed to generate new dentine.

 

Ibuprofen associated with blood pressure rise in arthritis patients at CVD risk

According to the European Society of Cardiology, ibuprofen is associated with increased blood pressure and hypertension compared to celecoxib in patients with osteoarthritis or rheumatoid arthritis and increased risk of cardiovascular disease.

Nonsteroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but are now linked with increased blood pressure and adverse cardiovascular events.

NSAID labels include warnings about potential increases in blood pressure but there is little data on the effects of individual drugs. Maintaining or achieving blood pressure control in patients with arthritis and concomitant hypertension could avoid more than 70,000 deaths from stroke and 60,000 deaths from coronary heart disease each year.

The study which found the results, PRECISION-ABPM, was a prospective, double blind, randomised, non-inferiority cardiovascular safety trial. It was conducted at 60 sites in the US and included 444 patients, of whom 408 (92%) had osteoarthritis and 36 (8%) had rheumatoid arthritis. All patients had evidence of, or were at increased risk for, coronary artery disease.

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Patients were randomised in a 1:1:1 fashion to receive celecoxib (100–200mg twice a day), ibuprofen (600–800mg three times a day), or naproxen (375–500mg twice a day) with matching placebos.

Principal investigator Prof Frank Ruschitzka, professor of cardiology and co-head, Department of Cardiology, University Heart Centre, Zurich, Switzerland, said: “PRECISION-ABPM showed differential blood pressure effects between the different NSAIDs, ibuprofen and naproxen, and the COX-2 inhibitor celecoxib. While celecoxib and naproxen produced either a slight decrease (celecoxib) or a relatively small increase (naproxen) in blood pressure, ibuprofen was associated with a significant increase in ambulatory systolic blood pressure of more than 3mmHg.”

“Patients receiving ibuprofen had a 61% higher incidence of de novo hypertension compared to those receiving celecoxib,” Prof Ruschitzka continued.

These results support and extend the findings of the PRECISION trial, demonstrating non-inferiority for the primary cardiovascular outcomes for moderate doses of celecoxib compared with naproxen or ibuprofen.

HIV / AIDS home test kits seized over potential false results

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized 114 Hightop HIV/AIDS Home Test Kits, which could be potentially misleading in providing false results. The agency has advised that anyone who has used the kit should seek a further HIV test at a local sexual health clinic or through a GP.

A statement issued by the MHRA stated: “All UK based stock of Hightop HIV/AIDS Home Test Kit have been seized by MHRA and all sales of the product into the UK market have been stopped by the manufacturer”

The statement continued: “The HIV kits, manufactured by Qingdao Hightop Biotech Co Ltd, do not have a valid CE mark which means the product has not met a number of regulatory requirements concerning test performance, labelling and instructions for use.”

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Self-testing kits for HIV became legal in the UK from 6 April 2014, but buyers have always been warned to carefully check the CE mark before purchasing any kit. Self-test kit users who purchase kits online or from the high street should know what they are buying is safe and reliable. MHRA is currently investigating the issue with experts at Public Health England.

John Wilkinson, MHRA’s director of devices commented: “If you are concerned you may have used an unreliable test kit, speak to your GP, sexual health clinic, pharmacist or other healthcare professional”. He further added: “Make sure the kit has a CE mark and clearly states that it is intended for home self-testing. Don’t use a test kit if it’s damaged or the seal is broken.”

MHRA strongly suggests consumers should only buy a self-test kit from a reputable source, such as an online pharmacy registered with the MHRA. In the UK, online pharmacies must be registered with the MHRA and display the European common logo on every page of their website. While home self-test kits for HIV and STIs have many benefits, including letting people test in their own space and on their own terms, there’s equal concern surrounding their use.

According to recent surveys there are more than 100,000 people living with HIV in the UK and around a quarter of them don’t know they’re HIV positive.

Vitamin B3 could prevent miscarriages and birth defects

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An extra dose of vitamin B3 might help prevent certain kinds of complex birth defects, according to a new study. It is thought the vitamin can help compensate for defects in the body’s ability to make a molecule, nicotinamide adenine dinucleotide (NAD), which researchers have now linked for the first time to healthy fetal development in humans.

Every year 7.9 million babies are born with a birth defect worldwide. The discovery suggests the possibility that boosting levels of B3 in pregnant women’s diets might help lower overall rates of birth defects.

Researchers from the Victor Chang Institute in Sydney called it ‘a double breakthrough’ as they found both a cause and a preventative solution. The researchers analysed the DNA of four families where the mothers had suffered multiple miscarriages or their babies were born with multiple birth defects, such as heart, kidney, vertebrae and cleft palate problems.

They found mutations in two genes that caused the child to be deficient in a vital molecule known as Nicotinamide adenine dinucleotide (NAD), which allows cells to generate energy and organs to develop normally. Lead researcher Prof Sally Dunwoodie replicated these mutations in mice and found they could be corrected if the pregnant mother took niacin (vitamin B3).

“You can boost your levels of NAD and completely prevent the miscarriages and birth defects. It bypasses the genetic problem,” she said. “It’s rare that you find a cause and a prevention in the same study. And the prevention is so simple, it’s a vitamin,” she said.

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Back In 2005, Dunwoodie’s team dealt with a particularly severe case, a baby who had major defects in the heart, backbone, and ribs; the rib problems being so bad that the child’s lungs couldn’t fully inflate. The team found that the family carried a mutation in a gene related to the production of NAD, a molecule crucial for energy storage and DNA synthesis in cells. Both parents carried a mutation in one of their copies of the gene, and the affected baby had inherited two defective copies.

No one had reported any role for NAD in heart or bone development, Dunwoodie says. “We didn’t know what to do with it.”

To confirm the role of the mutations in organ and bone development, the researchers knocked out the two genes in mice to see whether similar birth defects appeared. At first all the pups were normal. But then the researchers realised that standard mouse chow is rich in niacin and that cells can use either niacin or nicotinamide—both known together as vitamin B3—to make NAD by an alternate pathway.

The work opens a potentially exciting new area of research for developmental biologists: Trying to understand how cell metabolism affects development