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Midodrine SCP, Midodrine ANS, Vasodrine

Sponsor
Southern Cross Pharma Pty Ltd
ARTGs
Device/Product name
Midodrine SCP, Midodrine ANS, Vasodrine
Active Ingredient
Midodrine hydrochloride
Date of decision
Published
ATC codes
C01CA17
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Midodrine SCP, Midodrine ANS and Vasodrine was considered favourable for the therapeutic use approved.
What steps were involved in the decision process

Registration timeline

The following table summarises the key steps and dates for this application.

Description Date
Submission dossier accepted and first round evaluation commenced 2 October 2018
First round evaluation completed 29 April 2019
Sponsor provides responses on questions raised in first round evaluation 9 July 2019
Second round evaluation completed 14 August 2019
Delegate's overall benefit-risk assessment and request for Advisory Committee advice 9 September 2019
Sponsor's pre-Advisory Committee response 15 September 2019
Advisory Committee meeting 4 October 2019
Registration decision (Outcome) 4 December 2019
Completion of administrative activities and registration on ARTG 18 December 2019
Number of working days from submission dossier acceptance to registration decision* 247

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Tablet
Strength
2.5 mg and 5 mg
Other ingredients
Microcrystalline cellulose, Pregelatinised maize starch, Magnesium stearate, Colloidal anhydrous silica
Containers
Blister pack
Pack sizes
60, 90 and 500 tablets
Routes of administration
Oral
Dosage

The initiation of midodrine should be undertaken under close medical supervision in a controlled clinical setting by a specialist with expertise in the treatment of severe orthostatic hypotension.

Initial dose: 2.5 mg three times a day. Depending on the results of supine and standing blood pressure recordings, this dose may be increased weekly up to a dose of 10 mg three times a day. This is the usual maintenance dosage. The maximum recommended dose should not exceed 30 mg daily.

For further information refer to the Product Information.

Pregnancy category
CDrugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved

Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) were approved for the following therapeutic use:

Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) are indicated in adults for the treatment of severe symptomatic orthostatic hypotension due to autonomic dysfunction when exacerbating factors have been addressed and other forms of treatment remain inadequate.
What is this medicine and how does it work
Midodrine is the rapidly absorbed prodrug of the pharmacologically active constituent desglymidodrine.Desglymidodrine is a sympathomimetic agent with a direct and selective effect on the peripheral alpha 1 (α1)-adrenergic receptors. This α1-stimulative effect induces vasoconstriction of the venous system (causing a reduction in venous pooling). The α1-adrenergic effects of desglymidodrine are almost wholly attributable to the (-) enantiomer of desglymidodrine. After taking midodrine, which is a racemic mixture, (+) desglymidodrine is also present, though this contributes almost nothing to the desired effect.Desglymidodrine increases the peripheral arterial resistance, resulting in an increase in arterial blood pressure.Nonclinical experiments showed that midodrine had a selective effect on blood flow in various vascular beds, with the most effect observed in the femoral artery, and least in the mesenteric artery.Only limited data is available on the long-term effects of taking midodrine.Stimulation of the α-adrenergic receptors of the bladder and the ureter increases the sphincter muscle tone.Desglymidodrine has no beta (β)-adrenergic effects.
What post-market commitments will the sponsor undertake
  • Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) are to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Midodrine SCP (midodrine hydrochloride), Midodrine ANS (midodrine hydrochloride) and Vasodrine (midodrine hydrochloride) Australian-Risk Management Plan (AUS-RMP) (version 1.2, dated November 2019, data lock point 23 April 2018), included with submission PM-2018-02754-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs). Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of this approval letter.

The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

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