Project 1 - buccal film against epilepsy seizures
Current treatment options and market
Prolonged or repetitive seizures, which is sometimes called status epilepticus, is a condition that may cause long-term harm. For this reason, specific medicines may have to be administered to stop these seizures. As a patient suffering from a seizure is normally unable to self-administer medications, these products have to be administered by a parent, a personal care assistant, a nurse or other caretaker. The most used product in Europe at present is Buccolam oromucosal solution, which contains the anticonvulsant substance midazolam. The previous dominant treatment, rectal diazepam, is still used, despite not being particularly user-friendly. Buccolam costs approximately 25 EUR per dose at the pharmacy, and we estimate that pharmacy sales of Buccolam and other oromucosal midazolam solutions amount to at least 50 MEUR million annually.
Buccolam is not available in the USA, where the preferred treatment option is a nasal spray called Nayzilam. Nayzilam costs more than $300 per dose, and we estimate that annual sales amount to at least $75M. The less patient-friendly treatment rectal diazepam is still used in the US, at price of $150 or more.
SWIPP’s buccal midazolam film
This product is designed to be an alternative to existing midazolam and diazepam products. It offers a number of advantages: it is easy to carry along; it is not sensitive to heat or cold; it is quick and easy to use; it does not run out of the mouth; and it cannot be swallowed or inhaled. The production costs are also relatively low. SWIPP has carried out two clinical studies with successful results: SWIPP-010 and SWIPP-012, in which SWIPP’s buccal midazolam film has been compared with an oromucosal midazolam solution in healthy adult volunteers. The next step is a pivotal study, for market approval. This is scheduled for late 2023, after which the product can be approved in the EU in 2024.
SWIPP’s buccal film has the potential to compete with both Buccolam and Nayzilam, a statement supported by market research conducted in spring 2022 among epilepsy specialists in Europe and the USA. However, in the US, clinical studies on epilepsy patients are required before the product can be approved for marketing.
We therefore start with an EU approval, which does not require clinical studies in patients. Once EU approval has been granted, approval in other countries may follow, for example, the United Kingdom, Switzerland, Australia, etc.
Project 2 - oral film for moderate sedation
Current treatment options and market
There are many situations within health care that require the use of so-called moderate sedation. For example, as premedication before general anaesthesia, or to relax patients prior to diagnostic procedures such as gastroscopy or endoscopy. There is also a need for moderate sedation in children undergoing complex dental treatments. Midazolam is suitable for this purpose because it has a rapid onset of action and a rapid elimination. Solutions for injection containing midazolam, though administered orally, are currently used for this purpose, despite the fact that this is not an officially approved indication for such products. There are also oral midazolam solutions that have been specifically developed and approved for moderate sedation, both in Europe and in the USA. The price for a modern single-dose product may be more than 20 EUR per dose. It is SWIPP’s assessment that the market potential for products for moderate sedation is at least 100 MEUR annually.
SWIPP’s oral midazolam film
SWIPP’s oral film is designed to be an alternative to existing products that contain midazolam and similar substances. It offers several advantages: it is not sensitive to heat or cold; it is quick and easy to use; it does not run out of the mouth; and it cannot be spat out, which is a particular advantage in children’s dental treatment. SWIPP has conducted a successful clinical study in healthy adult volunteers (SWIPP-011), in which SWIPP’s oral midazolam film has been compared with an oral solution and with an intramuscular injection. The next step is to discuss Project 2 with the FDA, in a pre-IND meeting scheduled for 2022 Q4. The guidance provided at that meeting will also be relevant for EU and other regulatory environments, and to some extent also for Project 1.