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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.

 

SUMMARY

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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NEWS HIGHLIGHTS

Media Articles Related to Oxsoralen-Ultra (Methoxsalen)

CHMP Backs Secukinumab, Apremilast for Psoriasis
Source: Medscape Medical News Headlines [2014.11.21]
The European Medicines Agency committee has recommended secukinumab and apremilast for moderate to severe plaque psoriasis and apremilast for active psoriatic arthritis.
International Approvals

Positive results from second pivotal Phase 3 study of Brodalumab in patients with moderate-to-severe plaque psoriasis announced
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.11.13]
Amgen and AstraZeneca has announced that AMAGINE-3(TM), a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis...

Brodalumab Beats Stelara in Psoriasis Trial, Sponsors Say
Source: MedPage Today Dermatology [2014.11.11]
(MedPage Today) -- More patients achieve total plaque clearance in topline results.

New research reveals true impact of psoriasis
Source: Dermatology News From Medical News Today [2014.11.03]
Innovative research published in the latest edition of the British Journal of Dermatology reveals the causes behind the emotional distress experienced by people with psoriasis.

Lesion-healing mechanism identified in psoriasis
Source: Dermatology News From Medical News Today [2014.10.29]
A UC Irvine-led study has revealed the underlying genetic factors that help repair skin lesions caused by psoriasis, which could engender new methods of controlling the lingering condition.Dr.

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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)

A Safety and Efficacy Study of Uvadex and Extracorporeal Photopheresis (ECP) in Chronic Graft Versus Host Disease [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.

Fumaric Acid Ester-PUVA Therapy Versus Acitretin -PUVA Therapy in Pustular Palmoplantar Psoriasis [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.

RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART) [Recruiting]
The objectives of this clinical trial are to:

- Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing

agent Uvadex in the treatment of HIV-1 infection;

- Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction

(PCR) analysis;

- Evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio;

- Evaluate the effects of this therapy on the patient's immune system, by skin reactivity

to a standard anergy panel.

PUVA Maintenance Therapy in Mycosis Fungoides [Not yet recruiting]
The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis fungoides) patients.

Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-Versus-Host Disease [Active, not recruiting]
The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease (GvHD).

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Page last updated: 2014-11-21

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