Lawley Pharmaceuticals

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Lawley Pharmaceuticals
Company typePrivate
IndustryPharmaceuticals
Founded1995
FounderMichael John Buckley
HeadquartersPerth, West Leederville, Western Australia
Key people
Michael Buckley (CEO) & Medical Director
Websitewww.lawleypharm.com.au

Lawley Pharmaceuticals is a privately owned Australian pharmaceutical company established by pharmacist Michael Buckley in 1995.[1]

The company specializes in the manufacture of pharmaceutical-grade hormone replacement therapies and is focused on the development of testosterone and progesterone creams for the treatment of various endocrine deficiencies and medical conditions.[2]

Manufacturing

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Lawley are manufacturing partners with Perrigo Laboratories Pty Ltd., formerly called Orion Laboratories, in Balcatta, Western Australia. Perrigo is an Australian government approved facility, listed on the Australian Register of Therapeutic Goods.[3] The facility was TGA approved in January 2004 and fully commissioned in August 2004.

Medical Research and Clinical Trials

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Lawley's research and clinical trials take place in Australia and the United States, where the company is involved in the process of developing and testing new treatment options in therapeutic areas of men's and women's health. Specific areas of interest include andrology, gynaecology, urology and endocrinology.

Results of Completed Clinical Trials

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Between 2000 and 2004, research by Lawley mainly focused on the clinical efficacy of their creams AndroFeme[4] and AndroForte.[5]

Results of Lawley's other previous research demonstrated that topically applied progesterone is rapidly absorbed into the skin and transported through the body with a distribution pattern and metabolism comparable to those previously reported for intravascularly administered progesterone.[6][7] In 2003, a study aiming at evaluating the efficacy of transdermal testosterone therapy found that such a treatment improves well-being, mood, and sexual function in pre-menopausal women with low libido and low testosterone.[8][9] Another clinical trial published by Climacteric in 2007, further confirmed that Testosterone cream significantly improves sexual scores in menopausal women with low sexual desire.[10]

References

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  1. ^ "Company Overview of Lawley Pharmaceuticals". www.businessweek.com. Bloomberg Businessweek. Retrieved 17 November 2014.
  2. ^ "Company Profile". www.evaluategroup.com. Evaluate Ltd. Retrieved 17 November 2014.
  3. ^ "Australian Approved Manufacturer". www.ebs.tga.gov.au/. TGA - Therapeutic Goods Administration. Retrieved 17 November 2014.
  4. ^ Eden, John. "A Pilot Study of AndroFeme Cream (1% Testosterone)" (PDF). www.lawleypharm.com.au/pdfs/trial_pilot-study-androfeme-2000.pdf. Sydney Menopause Centre Royal Hospital for Women: Lawley Pharmaceuticals. Archived from the original (PDF) on 25 January 2014. Retrieved 4 February 2015.
  5. ^ Handelsman, DJ; Kelleher, S; Ly, LP; Jiminez, M. "Long-Term Pharmacokinetics and Clinical Efficacy of Andromen® Forte 5% Cream for Androgen Replacement Therapy in Hypogonadal Men" (PDF). www.lawleypharm.com.au. ANZAC Research Institute, Department of Andrology, Concord Hospital, Sydney, 2004. Archived from the original (PDF) on 25 January 2014. Retrieved 4 February 2015.
  6. ^ Waddell, Brendan J.; O’Leary, Peter C. (April 2002). "Distribution and metabolism of topically applied progesterone in a rat model". The Journal of Steroid Biochemistry and Molecular Biology. 80 (4–5): 449–455. doi:10.1016/S0960-0760(02)00032-8. PMID 11983492.
  7. ^ O'Leary, P; Feddema, P; Chan, K; Taranto, M; Smith, M; Evans, S (November 2000). "Salivary, but not serum or urinary levels of progesterone are elevated after topical application of progesterone cream to pre-and postmenopausal women". Clinical Endocrinology. 53 (5): 615–20. doi:10.1046/j.1365-2265.2000.01130.x. PMID 11106923.
  8. ^ Goldstat, Rebecca; Briganti, Esther; Tran, Jane; Wolfe, Rory; Davis, Susan R. (September 2003). "Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women" (PDF). Menopause. 10 (5): 390–398. CiteSeerX 10.1.1.692.6678. doi:10.1097/01.GME.0000060256.03945.20. PMID 14501599. Archived from the original (PDF) on 25 January 2014. Retrieved 4 February 2015.
  9. ^ Abdallah, R T; Simon, J A (21 June 2007). "Testosterone therapy in women: its role in the management of hypoactive sexual desire disorder". International Journal of Impotence Research. 19 (5): 458–463. doi:10.1038/sj.ijir.3901558. PMID 17581596.
  10. ^ El-Hage, G; Eden, JA; Manga, RZ (August 2007). "A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder". Climacteric. 10 (4): 335–43. doi:10.1080/13697130701364644. PMID 17653960.

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