A Clinical Study Of 22.5 mg. La-2550: A New Subcutaneous Depot Delivery System For Leuprolide Acetate For The Treatment Of Prostate Cancer

Chu, Franklin; Jayson, Maury; Dineen, Martin; Pérez, Ramón; Harkaway, Richard C.; Tyler, Robert Claude

doi:10.1016/s0022-5347(05)64625-3

Cited by 79 publications

(57 citation statements)

References 18 publications

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“…The frequency of injection-site-related complaints – typical for subcutaneous injectable products – in this real-life MANTA study was comparable to what was observed in the clinical trials [6, 7]. However, in the current study, physicians were asked specifically to describe all complaints related to injection of the LA depot formulation (pain, hematoma, tumor flare, etc.…”

Section: Discussionsupporting

confidence: 70%

“…With regard to safety and tolerability, fewer patients experienced TEAE in daily clinical practice than in the clinical trials with the 1- and 3-month LA depot formulation [6, 7]. The frequency of injection-site-related complaints – typical for subcutaneous injectable products – in this real-life MANTA study was comparable to what was observed in the clinical trials [6, 7].…”

Section: Discussionsupporting

confidence: 52%

“…As such, the results of this MANTA study are an external validation of the clinical trial results [6, 7], showing that the 1- and 3-month LA depot formulations can reliably suppress serum PSA and testosterone levels. However, in contrast to the clinical trials, the MANTA study includes a heterogeneous group of patients, more accurately reflecting daily clinical practice.…”

Section: Discussionmentioning

confidence: 88%

“…Moreover, 83% of physicians indicated that the patient had partially or completely responded to treatment at the final visit, resulting in improvement or stabilization of the patient's condition in > 90% of patients. These results indicate that the efficacy results of the clinical trials for the 1- and 3-month LA depot formulation [6, 7] also apply to a broad patient population encountered in daily clinical practice.…”

Section: Discussionmentioning

confidence: 93%

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Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard ® /Depo-Eligard ® ) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study

Braeckman¹,

Michielsen²

2014

aoms

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IntroductionThe 1-, 3- and 6- month biodegradable polymer matrix depot formulations of leuprorelin acetate (Eligard®/Depo-Eligard®, Astellas Pharma Inc/BV) were shown to reduce testosterone and prostate-specific antigen levels and to be well tolerated in patients with advanced prostate cancer in several clinical trials. This study aimed at evaluating the efficacy, safety and tolerability of the 1- and 3-month leuprorelin acetate depot formulations in daily clinical practice.Material and methodsA prospective, open-label, non-interventional, phase IV study (MANTA) was conducted in 243 Belgian prostate cancer patients who had been prescribed the 1-month (7.5 mg) or 3-month (22.5 mg) leuprorelin acetate depot formulation. Patients were followed for at least 3 months.ResultsMedian serum prostate-specific antigen levels were reduced by 95% from 12.0 ng/ml at baseline to 0.60 ng/ml after a median follow-up time of 132 days, while median testosterone levels were reduced by 94% from 360 ng/dl to 20 ng/dl. Partial or complete treatment response was observed in 83% of patients at the final visit (according to the physician's assessment). Ninety-two patients (37.86%) experienced treatment-emergent adverse events, with injection site-related reactions, hot flushes and tumor flare being the most common ones. Overall safety and tolerability of the leuprorelin acetate depot formulation were rated as good or excellent by 90% of physicians.ConclusionsThese data are consistent with efficacy and tolerability results from clinical trials. They confirm that the 1- and 3-month leuprorelin acetate depot formulations are well tolerated and reliably lower serum prostate-specific antigen and testosterone levels in routine clinical practice.

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Section: Discussionsupporting

confidence: 70%

Section: Discussionsupporting

confidence: 52%

Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 93%

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Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard ® /Depo-Eligard ® ) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study

Braeckman¹,

Michielsen²

2014

aoms

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“…For the in vitro studies, the drug is combined with the polymer solution and small drops of the mixture (about 50 mg) are added to phosphate-buffered saline solution. The receiving fluid is replaced at selected times with fresh solution, and the removed phosphate buffer saline solution is analyzed for drug concentration using a variety of analytical methods [13].…”

Section: Fig 1: Controlled Release By Atrigel Systemmentioning

confidence: 99%

A Review On: Atrigel–the Magical Tool

Sali

Gondkar

Saudagar

2018

Int J Curr Pharm Sci

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The widely effective and most common form of drug delivery is parenteral administration for active drug substances with poor bio-availability and the drugs with a narrow therapeutic index. Though parenteral administration of drug is often critical and associated with problems such as limited number of acceptable excipients, stringent requirements of aseptic production process, safety issues, patient noncompliance. Still this route maintains its value due to special advantages like quicker onset of action in case of emergency, target the drug quickly to desired site of action, prevention of first pass metabolism etc. The application of advanced drug delivery technology to parenteral administration lead to development of liposomes, nanosuspensions, solid implants etc. to overcome limitations of conventional parenteral delivery. Solid implants are reported to produce very reproducible release profiles. However, because of their size, they require surgical implantation or the use of large trochars to administer the product. Delivery systems consisting of microparticles can be injected into the body using conventional needles and syringes and have been the most widely accepted biodegradable polymer system for parenteral use. However, the manufacturing processes for microparticles are often complex and difficult to control leading to batch-to-batch product non uniformity. These methods of administration often limit the product's market potential due to patient and physician acceptance issues. Therefore, a delivery system that combines the simplicity and reliability of solid implant devices along with convenience and ease of administration of microparticles is desired. In situ gel forming systems represent a desired alternate. This article gives the idea about In situ gel forming system to provide drug release in sustained release manner.

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Lactide and Glycolide Polymers

Letchford

Södergård

Plackett

et al. 2011

Biodegradable Polymers in Clinical Use and Clinical Development

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A Clinical Study Of 22.5 mg. La-2550: A New Subcutaneous Depot Delivery System For Leuprolide Acetate For The Treatment Of Prostate Cancer

Abstract: LA-2550 (22.5 mg. depot) produced and maintained safe and effective suppression of serum testosterone to well below the medical castrate level of 50 ng./dl. or less.

Cited by 79 publications

References 18 publications

Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard ® /Depo-Eligard ® ) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study

Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard ® /Depo-Eligard ® ) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study

A Review On: Atrigel–the Magical Tool

Lactide and Glycolide Polymers

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