Sedana Medical AB (publ) (“Sedana Medical”) is a pioneer medtech and pharmaceutical company focused on inhaled sedation for mechanically ventilated patients in intensive care.

Purpose

Sedana Medical is committed through innovative science to improve the patient’s life during and beyond sedation. Patient safety is paramount, and the goal is ultimately to provide therapies to patients who might benefit from them while not exposing them to undue risk.

Sedana Medical believes that investigational drugs (not yet approved by the relevant health authorities) should be studied in patients as part of clinical trials designed to generate data on safety and efficacy.  This data can be used to support regulatory applications, ultimately resulting in new, approved medicines.  Sedana Medical encourages a dialogue between the patients and their physicians to find opportunities to participate in clinical trials wherever possible.

In some cases, patients are not eligible for ongoing clinical trials, or clinical trials may not be recruiting in their geographical region. In addition, investigational drugs may not be available between the completion of the registrational clinical trials and regulatory approval or commercial availability. When patients have exhausted all available therapies, Sedana Medical may consider providing an investigational drug outside of a clinical trial through an Early Access Program.

General Information on Early Access Programs

There exist a variety of local regulations and mechanisms to provide investigational products before regulatory approval or commercial access. Different terms exist locally for these pre-approval access provisions including “Compassionate Use Program”, “Expanded Access Program”, “Named Patient Program”, “Special Access Schemes/Programs”. At Sedana Medical, “Early Access Programs” (EAPs) refer to the mechanisms to provide access to a product outside of clinical trials and before regulatory approval and commercial availability.  An Early Access Program (EAP) is intended to provide compassionate use access to, and supply of, an investigational drug when there is evidence that a patient may benefit from treatment prior to regulatory approval and commercial availability of the drug.

Sedana Medical cohort programs will only take place in countries where Sedana Medical intends to seek regulatory approval. Relevant approval by the local Medical Products Agency or other competent authority will be sought for either route to early access.

General Criteria

Sedana Medical will evaluate the following criteria before setting up a program (where permitted by local regulation) or considering individual patient requests:

• The specific type of program being proposed is permitted according to the local country specific regulations and laws.
• The investigational drug is not commercially available for the requested indication in the country concerned.
• The patient is not eligible for, or does not have access to, an ongoing clinical study of the investigational drug.
• The investigational drug is intended to undergo regulatory approval.
• Early access cannot be granted if there still is insufficient clinical evidence of benefit from the use of an investigational drug, or if the treatment would pose or is anticipated to pose an unacceptable or excessive risk to the patient.
• The investigational drug will be used as treatment for a serious or life-threatening disease as defined by laws and regulations of the country concerned.
• The patient in question cannot be treated satisfactorily with other drugs approved and commercially available in the same indication.
• Requests for an investigational drug under an EAP must originate from appropriately qualified physician licensed in the country where the investigational drug is to be distributed.
• The treating physician(s) must be appropriately qualified to administer the investigational drug and follow all relevant safety requirements and procedures.
• The physician attending to the patient(s) for whom access is sought agrees to comply with all applicable local legal and regulatory requirements in relation to the request, and any requirements in terms of eligibility criteria, safety reporting or other data provision as stipulated by Sedana Medical.

Closing of Early Access Program

Sedana Medical may consider closing a program for various reasons related to the investigational drug, including but not limited to:

• Commercial availability for a particular need or condition

• A negative regulatory decision
• New information becomes available about the safety that could substantially change its benefit/risk profile
• Limited supply or other manufacturing issues

Process for Requesting Access

Currently we have an Expanded Access Program open in the US.

Early Access requests should be submitted by the treating licensed physician and should include sufficient supporting detail to enable Sedana Medical to evaluate the early access request.  Please include contact information including address, phone number and email address.  Please note that training is needed and when evaluating a request it is also dependent on our training resources.

Contact Information:

Sedana Medicals Global Medical Information: medinfo@sedanamedical.com.

The INSPiRE-ICU (Inhaled Sedation vs Propofol in Respiratory failure) studies (SED003 and SED004) are two identical phase III studies aiming to confirm the efficacy and safety of inhaled isoflurane, delivered via the Sedaconda ACD, for the sedation of adult mechanically ventilated ICU patients, in comparison to intravenous infusion of propofol.

The results of the studies will form the basis of a new drug application (NDA) filing at the US Food and Drug Administration (FDA).

The primary endpoint will be the proportion of time spent within the target range of sedation depth in absence of rescue sedation, as assessed according to the Richmond Agitation Sedation Scale (RASS). In addition, the studies will investigate several secondary endpoints, including the use of opioids, the wake-up time, the cognitive recovery after end of sedation, and the spontaneous breathing effort.

The studies will enrol a total of 470 adult patients across 25-30 sites in the US. The first patient was enrolled in April 2022.

Further information on the studies is available at www.clinicaltrials.gov (NCT05312385 for SED003 and NCT05327296 for SED004).

In 2021, Sedana Medical initiated the IsoCOMFORT study (SED002), a paediatric phase III study aiming to investigate whether sedation with Sedaconda (isoflurane) delivered via the Sedaconda ACD, is safe and more effective than intravenously administered midazolam in mechanically ventilated ICU paediatric patients between 3-17 years old.

Currently, midazolam is the only sedation option for children in ICU because propofol is contraindicated due to the risk of serious adverse events. The patients will be sedated for 12–48 hours with either sedation method, and the primary endpoint will be the proportion of time spent at adequate sedation depth.

The study will involve 160 patients from intensive care clinics in Germany, France, Spain, Sweden, and the UK. The results of the study are expected to lead to an approved paediatric indication for inhaled sedation.

Patient enrolment was completed during 2023.

Further information on the study is available at www.clinicaltrials.gov (NCT04684238).

In 2020, Sedana Medical completed the Sedaconda study (SED001), the largest randomised, controlled, open-label trial performed to date on inhaled sedation in intensive care.

The phase III study aimed to confirm the efficacy and safety of sedation with Sedaconda (isoflurane) delivered via the Sedaconda ACD in mechanically ventilated ICU patients, comparing it to standard sedation with intravenously administered propofol. A total of 301 patients from 24 intensive care clinics in Germany and Slovenia were randomized to either sedation method.

The study successfully reached its primary endpoint, demonstrating Sedaconda’s non-inferiority to intravenous propofol in maintaining an adequate depth of sedation. Additionally, the results showed that sedation with Sedaconda reduced the need for opioids, facilitated spontaneous breathing, and enabled a faster and more predictable awakening. In terms of safety, Sedaconda was well tolerated, with a safety profile consistent with previous findings for isoflurane.

The results were published in The Lancet Respiratory Medicine journal (Meiser et al., 2021) and constituted the basis for Sedana Medical’s European marketing approval for Sedaconda for inhaled sedation.