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Q What is the new product that DuoCort is developing all about? |
A DuoCort´s new product is a once daily, dual-release hydrocortisone tablet to be used as replacement therapy for patients with adrenal insufficiency.
The new therapy will:
• More closely mimic the natural biological rhythm of cortisol.
• Be a convenient once-daily medication which may improve compliance compared to multiple daily dose therapy
• Have a higher initial cortisol exposure after tablet intake than current therapy.
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| Q How does the new product work? / What is meant by dual release? |
| A It is a single tablet combining both rapid release and extended release characteristics. In order to better mimic the normal cortisol release profile, the new dual-release tablet is administered in the morning on an empty stomach with a glass of water. It achieves rapid onset of part of the total dose, followed by the slow release of the remainder of the dose over the rest of the day. With a cortisol-free interval during the night, the new tablet closely mimics the physiological serum cortisol profile. |
| Q Who can benefit from treatment with DuoCort´s new product? |
| A All patients who need replacement therapy for adrenal insufficiency. |
| Q What is different with DuoCort´s new product compared to currently available therapies? |
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With its new and optimized drug delivery format, the once daily dual-release hydrocortisone tablet will address several problems.
By achieving a higher initial cortisol exposure after tablet intake, than current therapy followed by an extended release over the day, the new therapy will quickly after waking give the patient the high morning levels that naturally occur, the declining levels needed over the rest of the day, and a cortisol-free interval at night – thus closely mimicking the natural biological rhythm of cortisol.
A more physiological cortisol replacement means improved cortisol exposure over the day for reduced fatigue and the convenience of only having to take medication in the morning, along with better quality of life and general sense of well-being, and better long-term outcomes. These potential benefits are now being assessed in clinical trials.
The new dual release hydrocortisone tablet will give physicians more therapeutic options and enable them to reduce doses in some cases.
In addition, in cases of illness and other stress events in which extra doses of conventional tablets are now used, the new tablet will give the patient the same befit as conventional tablets. Also, the new tablet may have some extra benefits such as:
• higher initial cortisol exposure after tablet intake than current that their illness or other event demands and
• an extended release over the subsequent hours that they would not get with an ordinary tablet.
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| Q Why would a more physiological release profile be of benefit for patients? |
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A In healthy subjects the body´s normal cortisol production follows a distinct daily pattern. This means that cortisol levels vary during the 24 hour day. The cortisol levels are highest in the early morning hours, peak at around 7am, decline during the day to their lowest point which occurs by midnight and the early phase of sleep. This normal rhythm is controlled by the human body clock which is set according to light and dark exposure. In addition to this normal rhythm, cortisol secretion increases in response to any stress, whether physical or psychological.
You want a replacement treatment to mimic this normal rhythm as closely as possible in order keep the body’s rhythms as close to normal as possible and thereby improve body function and well-being. Today’s therapy cannot adequately mimic this rhythm. A once daily treatment also offers a more convenient alternative for patients and may improve compliance, which is important to keeping cortisol at the right level during the whole day and safer when there is less risk of missing a dose.
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| Q Many patients with adrenal insufficiency suffer from morning fatigue, will DuoCort´s new product solve that problem? |
A Morning fatigue is a big problem for around 40% of AI patients. DuoCort´s new product has a higher initial cortisol exposure after tablet intake, than currently available tablets.
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| Q Many patients with adrenal insufficiency suffer from poor quality of life (QoL). Will treatment with DuoCort´s new product improve that? |
| A The new product will more closely mimic the natural biological rhythm of cortisol. In the current clinical trial program QoL is one area that is being investigated. Once-daily administration can also contribute to less worry about forgetting tablets during the day and enable patients to have a more normal life. A once daily tablet is also inherently safer than multiple daily dose therapy. (Osterberg, Adherence to Medication, N Engl J Med 2005; 353: 487-97) |
| Q Where in clinical development is DuoCort´s new product? |
| A It is currently in late-stage clinical trials in Europe. The first part of the study is completed and the open extension is ongoing. |
| Q What did the phase I results show? |
A The Phase I trial evaluated the safety and pharmacokinetics of the new hydrocortisone tablets in healthy volunteers.
The data shows that both t5 mg and 20 mg dual-release hydrocortisone tablets were safe and well tolerated. The novel dual-release formulation showed a rapid increase in cortisol levels after single-dose administration, the dose was well absorbed and it had similar bioavailability to the oral hydrocortisone in the literature. Moreover, the data showed no risk of dose accumulation. The release profile closely resembled the physiological one, including the natural nocturnal cortisol free interval. |
| Q When will DuoCort´s product be on the market? |
| A We are expecting to be on the EU market in 2010 or 2011, subject to regulatory approval. Other countries will follow as quickly as the regulatory requirements can be fulfilled. |
| Q What does the orphan drug designation mean for DuoCort´s new product? |
| A The new dual release product has an orphan drug designation both in the US as well as in the EU. Orphan Drug legislation provides incentives to encourage the development and marketing of medicines for rare diseases such as adrenal insufficiency, including access to regulatory assistance during the development phase, reduced filing fees, and market exclusivity. |
| Q How much will DuoCort´s new product cost compared to today´s standard treatment? |
| A To recoup the investment in pharmaceutical and clinical research and other investments required to get an innovative drug like the DuoCort product approved and on the market, its price will most likely be higher than existing drugs for cortisol replacement, which have been on the market for years and have had very little invested in them in recent decades. Pricing, however, is something that will be decided together with pricing and drug reimbursement authorities at the time of approval. |
| Q Will you undertake sales and marketing yourselves of the new product? |
| A We are currently exploring a range of commercialisation options. |
