Pharmaceutical innovation has accelerated, but the way of dosing oral medicines to patients has broadly stayed the same. Prescription medicine delivered as tablets in a bottle often does not provide a good fit for patients or treatment goals. Now in development, OnDosis proprietary technology delivers flexible and individualised dosing of oral medicines formulated as granules. The product integrates oral prescription medicine with intelligent dosing in a handheld digital device. It is a prescribed regimen consisting of two parts: a re-usable Control Unit and a disposable pre-filled Cartridge with active medicine. The pre-filled cartridge communicates relevant information to the control unit. The cartridge enables the control unit to set a dose or a dosing schedule, prevent from taking more than the maximum dose, allows titration, ensure notification of tampering, and records drug dispensing.
One area of current development for OnDosis is to improve outcomes for Attention-deficit hyperactivity disorder (ADHD) treatment. Prevalence of ADHD has been estimated to be 11% in children and 4% in adults. Stimulants (methylphenidates and amphetamines) are the best-known and most widely used ADHD medications, despite concerns about their adverse effects and potential for abuse.
Market research on the target product profile conducted in the US with payers, pharmacists, patients and caregivers, underlines the key issues seen with treatment in the literature.
Key challenges can be categorised in three areas:
- Concern regarding abuse and misuse,
- The need for dose titration,
- Compliance and monitoring.
Physicians and payers were very interested in the ability to enable personalised user identification. ADHD medicines are controlled substances, yet 1 in 8 teenagers has misused or abused them, which increases to 1 in 5 among college students. Being digital, the product can incorporate user identification with a pin code or biometric identification. Participants saw this as providing reassurance against abuse - that the right patient is getting the right dose. In addition, the software controls how many doses are taken daily. Tamper proofing is also enabled through hardware and software.
Physicians and patients/caregivers were particularly supportive of the ability to dose titrate which can be difficult with current oral formulations. Stimulants for ADHD require substantial efforts in fine tuning and titration of doses for the maximum patient benefit without adverse effects. This product uses medication formulated as granules and dispensing with the device IP technology it can be accurately dose titrated. The dose can be easily adjusted on the device itself. The pre-filled cartridges provide information to the control unit on the maximum dose per day.
All participants of the market research were encouraged on the possibility to support compliance and monitoring for treatment of ADHD. This is a key challenge for children (even when treated by caregivers), adolescents and adults with ADHD. The product itself logs the time and dose taken and the display shows when the last dose was taken. With connectivity the device can be linked to a companion app on a smart phone to show a compliance log. Physicians, patients and caregivers identified this as a key opportunity to support treatment outcomes. This is especially the case for children where medication might be organised by different stakeholders during the day. In addition, adding in the ability to input self-monitoring of symptoms such as level of concentration, hyperactivity, behaviour, school work etc. could support dosing decisions by the physician and can lead to improvement in treatment outcomes.
Compliance can also be challenged due to issues with swallowing pills. This is a common issue for children and is also seen in 10-40% of adults. A qualitative investigation on how children received their medication highlighted that adult tablets are broken into smaller pieces, then crushed and added to food or liquid and, often parents resort to hiding, forcing administration or discontinue treatment completely after unsuccessful attempts. As the medication in the OnDosis device is dispensed as granules it can be mixed in liquid or soft food to help solve pill swallowing issues.
This qualitative market research confirmed that all respondent segments reacted positively to the target product profile. Eighty percent saw a place for it on the market and would agree to cover it in a co-payment status. The positive perception was confirmed in quantitative market analysis. The OnDosis product for ADHD treatment was scored 5.33 on a 1-7 scale. This score benchmarks it at the top level vs. results of other novel treatments. Moreover, a stated use reached a level of 1 in 3 patients across the ADHD treated population. For ADHD treatment the control unit would last for 12 months and the prefilled cartridges would be based on a one month or less prescription.
With connectivity, comes further opportunities to interact with an ecosystem of smart health technology such as wearables monitoring activity in ADHD. In the future and depending on data integrity the collection of data could either be used for electronic medical records or to develop more information regarding treatment outcomes.
Oral medication for ADHD can be improved to support the needs of patients, caregivers and health care professionals. OnDosis also has an exclusive collaboration to develop the technology for prescription medicines in all pain related indications. Treatment outcomes in other treatment areas can also benefit from improvements of integrating oral formulations with digital technology. Titration and compliance are critical for post organ transplant patients treated with immunosuppression drugs. Geriatric patient groups present issues with swallowing difficulties, compliance monitoring and dexterity issues with current tamper proof packaging. There is a definite need for a solution to support dose titration and swallowing issues with oral formulations for Paediatric patients. Through integrating medicine with intelligent dosing in a handheld digital device the company hope to address these challenges with oral medicines and therefore support improvements in treatment outcomes.