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Oxsoralen-Ultra (Methoxsalen) - Summary


CAUTION: Oxsoralen-Ultra® (Methoxsalen Soft Gelatin Capsules) should not be used interchangeably with regular Oxsoralen® or 8-MOP® (Methoxsalen Hard Gelatin Capsules). This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patients should be treated in accordance with the dosimetry specifically recommended for this product. The minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form should be determined.



Oxsoralen-Ultra (methoxsalen, 8-methoxypsoralen) Capsules, 10 mg. Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant and in the roots of Heracleum Candicans. It belongs to a group of compounds known as psoralens, or furocoumarins.

Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.

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Media Articles Related to Oxsoralen-Ultra (Methoxsalen)

Psoriasis Patients Face Increased Risk of Heart Attacks and Death
Source: Medscape Medical News Headlines [2017.09.29]
People with psoriasis, a chronic inflammatory disease, may be more likely than others to experience heart attacks and strokes at least in part because inflammation damages their vascular system, a recent study suggests.
Reuters Health Information

How Safe Are Various Systemic Therapies for Pediatric Psoriasis?
Source: Medscape Dermatology Headlines [2017.09.26]
Both methotrexate and TNF inhibitors appear to be safe for the majority of children, though cost is a big consideration.
Reuters Health Information

Psoriasis Quiz: Test Your Medical IQ
Source: MedicineNet Psoriasis Specialty [2017.09.19]
Title: Psoriasis Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 4/21/2011 3:23:00 PM
Last Editorial Review: 9/19/2017 6:17:30 PM

Severe Psoriasis Linked to Higher Risk of Earlier Death
Source: MedicineNet Psoriasis Specialty [2017.09.06]
Title: Severe Psoriasis Linked to Higher Risk of Earlier Death
Category: Health News
Created: 9/5/2017 12:00:00 AM
Last Editorial Review: 9/6/2017 12:00:00 AM

Is Psoriasis Contagious?
Source: MedicineNet Psoriasis Specialty [2017.09.05]
Title: Is Psoriasis Contagious?
Category: Diseases and Conditions
Created: 6/22/2015 12:00:00 AM
Last Editorial Review: 9/5/2017 12:00:00 AM

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Published Studies Related to Oxsoralen-Ultra (Methoxsalen)

Randomized, double-blind comparison of 1 mg/L versus 5 mg/L methoxsalen bath-PUVA therapy for chronic plaque-type psoriasis. [2006.10]
BACKGROUND: Bath-psoralen plus ultraviolet A (PUVA) radiation therapy is increasingly replacing oral PUVA because of its superior short- and long-term safety profile. Several investigations in recent years have led to a refinement of the bath-PUVA protocol; however, the optimal therapeutic concentration of methoxsalen in the bath water has as yet not been delineated. OBJECTIVES: The therapeutic efficacy and tolerability of bath-PUVA by using two different dilutions of methoxsalen (1 mg/L vs 5 mg/L or 0.0001% vs 0.0005%) were compared in 46 patients with chronic plaque-type psoriasis in a prospective, randomized, double-blind study... CONCLUSIONS: Our data indicate that in bath-PUVA treatment the use of a high (5 mg/L) methoxsalen concentration is substantially more effective in clearing chronic plaque-type psoriasis than a low (1 mg/L) concentration.

Single-dose methoxsalen effects on human cytochrome P-450 2A6 activity. [2000.01]
Methoxsalen (8-methoxypsoralen) is an effective and selective mechanism-based inhibitor of human hepatic cytochrome P-450 (CYP)2A6 in vitro, and may have utility as a clinical probe for CYP2A6-catalyzed xenobiotic metabolism in humans in vivo...

Comparison of minimal phototoxic dose and skin type for determining initial UVA dose in oral liquid methoxsalen photochemotherapy for the treatment of psoriasis. [1991.12]
Twenty-five patients with extensive psoriasis were randomly assigned into one of three groups, each receiving 0.5 mg/kg of oral liquid methoxsalen photochemotherapy followed 1 h later by exposure to long-wave ultraviolet light (UVA). The sole difference between the three groups was the method used to determine the initial UVA dose, which was either based on skin type, 25% of the minimal phototoxic dose (MPD), or 50% of the MPD...

Drug-drug interaction after single oral doses of the furanocoumarin methoxsalen and cyclosporine. [2006.07]
Furanocoumarins increase the bioavailability of drugs that are CYP3A4 substrates. A possible interaction of methoxsalen with cyclosporine was evaluated in 12 healthy volunteers following oral administration of 40 mg methoxsalen, 200 mg cyclosporine, or a combination of both in a randomized crossover study...

The effect of methoxsalen on nicotine and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) metabolism in vivo. [2003.12]
Nicotine is metabolized to the inactive metabolite cotinine by cytochrome P450 2A6. NNK, or 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone, is a potent procarcinogen shown to be activated to a reactive mutagenic metabolite by the enzyme CYP2A6...

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Clinical Trials Related to Oxsoralen-Ultra (Methoxsalen)

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease [Completed]
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i. e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.

A Safety and Efficacy Study of Uvadex and Extracorporeal Photopheresis (ECP) in Chronic Graft Versus Host Disease [Active, not recruiting]
The purpose of this study is to evaluate the safety and effectiveness of extracorporeal photopheresis therapy when added to standard drug therapies administered to patients with moderate to severe chronic graft-versus-host disease.

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease [Terminated]
The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

UVADEX and ECP for the Treatment of Pediatric Patients With Steroid Refractory Acute Graft Versus Host Disease [Not yet recruiting]
This is a single-arm, open-label, multicenter study of the efficacy of UVADEX (methoxsalen) Sterile Solution in conjunction with THERAKOS CELLEX Photopheresis Systems in pediatric patients with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and Follow-up Periods.

Fumaric Acid Ester-PUVA Therapy Versus Acitretin -PUVA Therapy in Pustular Palmoplantar Psoriasis [Active, not recruiting]
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with pustular palmoplantar psoriasis. Patients will be randomized and allocated in concealed manner to one of the two treatment arms: acitretin-PUVA or FAE-PUVA.

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Page last updated: 2017-09-29

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