Lawley Pharmaceuticals

Last updated

Lawley Pharmaceuticals
Type Private
Industry Pharmaceuticals
Founded1995
Founder Michael John Buckley
Headquarters Perth, West Leederville, Western Australia
Key people
Michael Buckley (CEO) & Medical Director
Website www.lawleypharm.com.au

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

Contents

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] In Men these disorders include Hypogonadism, Klinefelter's syndrome, low libido and castration. In Women these disorders include Endometriosis, Menopause, PCOS, Fibroids, Female Androgen deficiency, Infertility, Estrogen dominance, Menorrhagia and Hysterectomy.

Over the past 20 years, the company has grown to become a leader in the research and development of transdermal hormone preparations and is advancing clinical research using natural hormones.

History

Lawley Pharmaceuticals was founded in 1996 [3] as an offshoot from a retail company and is based in Perth, Western Australia.

Since its inception, the company has conducted extensive medical research, with the mission of establishing naturally occurring hormones (bio-identical hormone treatments) as cornerstone treatments for diseases such as breast cancer, infertility, sexual dysfunction, late-onset male hypogonadism, postpartum depression and endometriosis.

Today, Lawley's products have been subjected to clinical studies published in peer-reviewed journals including Menopause, [4] Climacteric [5] and The Journal of Steroid Biochemistry and Molecular Biology. [6]

Key Executives

Michael John Buckley is Australian citizen born on 20 May 1961. After attending the St. Kevins College in Melbourne, he went to the Victorian College of Pharmacy from where he received a Bachelor of Pharmacy in 1982. [7] Buckley moved to Perth in 1983 to work as pharmacist in both hospital and retail pharmacy environments.[ citation needed ]

After an extensive career in the pharmaceutical retail sector, Michael came to the conclusion that bio-identical hormones (Hormones matching chemicals that the body produces) must be better than using synthetic alternatives to treat disorders. To prove this, he devoted his further career to the understanding of the role and effectiveness of bio-identical hormones. Once convinced that bio-identical hormones were superior over their synthetic alternatives, he started the company Lawley Pharmaceuticals in 1995 to manufacture pharmaceutical grade bio-identical hormone creams for use by pharmacies, doctors, and hospitals. [8]

As the CEO and Medical Director of the company, Michael Buckley has directed research and development, clinical trial programs, the meeting of global regulatory requirements and marketing of Lawley’s transdermal hormone preparations. [9]

To date he has developed the optimal delivery systems for the administration of naturally occurring hormones to counter endocrine deficiency states. This success reflects Buckley’s commitment to the use of bio-identical hormones, in preference to a synthetic hormone analogue, specifically the hormones testosterone, progesterone and estradiol .

Michael Buckley is a member of the Australasian Menopause Society, The Pharmaceutical Society of Australia, [10] and The Pharmacy Guild of Australia.

Manufacturing

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. [11] The facility was TGA approved in January 2004 and fully commissioned in August 2004.

Products

Company products include AndroForte, [12] AndroFeme [13] and ProFeme, which are all TGA approved. [14]

Product Portfolio
Product NameActive IngredientsIndicationARTG Start DateOther products in this category
AndroFeme 1TestosteroneAndroFeme 1% is a transdermal bioidentical testosterone cream designed for women with testosterone deficiency and/or low libido. It was developed due to a rising concern over the lack of testosterone treatment available to women.23-02-2010 [15] N/A
AndroForte 5TestosteroneAndroForte 5% is a transdermal bioidentical testosterone cream. It helps men suffering from Klinefelters syndrome, hypogonadism and low testosterone amongst other diseases.21-10-2009 [16] AndroForte 2S - 2% scrotal testosterone
ProFeme 10ProgesteroneProFeme 10% is a pharmaceutical grade progesterone cream that treats women suffering from low progesterone levels, estrogen dominance and endocrine disorders. This cream covers women’s health issues where hormone replacement therapy is required.02-07-2003 [17] ProFeme 3.2%

Medical Research and Clinical Trials

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

Between 2000 and 2004, research by Lawley mainly focused on the clinical efficacy of their creams AndroFeme [18] and AndroForte. [19] [20] [21]

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] [22] 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. [23] [24] Another clinical trial published by Climacteric in 2007, further confirmed that Testosterone cream significantly improves sexual scores in menopausal women with low sexual desire. [25]

One of the most recent studies revealed that for women after menopause a low dose of 5 mg testosterone cream suffices to raise testosterone back to a premenopausal level. [4] [26]

Current Involvement in Research

The product AndroFeme, an androgen cream for women, is currently being studied in a collaborative study at Boston’s Massachusetts General Hospital conducted by Harvard Medical School Professor Karen K Miller, MD. [10] Other current studies are researching the effects of hormones on different conditions such as Alzheimer's disease, In vitro fertilisation (IVF), Depression, [27] and Dry Eye in postmenopausal women. [28]

Related Research Articles

<span class="mw-page-title-main">Progestogen (medication)</span> Medication producing effects similar to progesterone

A progestogen, also referred to as a progestagen, gestagen, or gestogen, is a type of medication which produces effects similar to those of the natural female sex hormone progesterone in the body. A progestin is a synthetic progestogen. Progestogens are used most commonly in hormonal birth control and menopausal hormone therapy. They can also be used in the treatment of gynecological conditions, to support fertility and pregnancy, to lower sex hormone levels for various purposes, and for other indications. Progestogens are used alone or in combination with estrogens. They are available in a wide variety of formulations and for use by many different routes of administration. Examples of progestogens include natural or bioidentical progesterone as well as progestins such as medroxyprogesterone acetate and norethisterone.

Hot flashes are a form of flushing, often caused by the changing hormone levels that are characteristic of menopause. They are typically experienced as a feeling of intense heat with sweating and rapid heartbeat, and may typically last from two to 30 minutes for each occurrence.

Bioidentical hormone replacement therapy (BHRT), also known as bioidentical hormone therapy(BHT) or natural hormone therapy, is the use of hormones that are identical on a molecular level with endogenous hormones in hormone replacement therapy. It may also be combined with blood and saliva testing of hormone levels, and the use of pharmacy compounding to obtain hormones in an effort to reach a targeted level of hormones in the body. A number of claims by some proponents of BHT have not been confirmed through scientific testing. Specific hormones used in BHT include estrone, estradiol, progesterone, testosterone, dehydroepiandrosterone (DHEA), and estriol.

Late-onset hypogonadism (LOH) or testosterone deficiency syndrome (TDS) is a condition in older men characterized by measurably low testosterone levels and clinical symptoms mostly of a sexual nature, including decreased desire for sex, fewer spontaneous erections, and erectile dysfunction. It is the result of a gradual drop in testosterone; a steady decline in testosterone levels of about 1% per year can happen and is well documented in both men and women.

<span class="mw-page-title-main">Drospirenone</span> Medication drug

Drospirenone is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses. It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin among others. The medication Is an analog of the drug spironolactone. Drospirenone is taken by mouth.

<span class="mw-page-title-main">Norethisterone acetate</span> Chemical compound

Norethisterone acetate (NETA), also known as norethindrone acetate and sold under the brand name Primolut-Nor among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. The medication available in low-dose and high-dose formulations and is used alone or in combination with an estrogen. It is ingested orally.

<span class="mw-page-title-main">Gestodene</span> Progestin medication

Gestodene, sold under the brand names Femodene and Minulet among others, is a progestin medication which is used in birth control pills for women. It is also used in menopausal hormone therapy. The medication is available almost exclusively in combination with an estrogen. It is taken by mouth.

Hormone replacement therapy (HRT), also known as menopausal hormone therapy or postmenopausal hormone therapy, is a form of hormone therapy used to treat symptoms associated with female menopause. These symptoms can include hot flashes, vaginal atrophy, accelerated skin aging, vaginal dryness, decreased muscle mass, sexual dysfunction, and bone loss or osteoporosis. They are in large part related to the diminished levels of sex hormones that occur during menopause.

<span class="mw-page-title-main">Medrogestone</span> Chemical compound

Medrogestone, sold under the brand name Colprone among others, is a progestin medication which has been used in menopausal hormone therapy and in the treatment of gynecological disorders. It is available both alone and in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Trimegestone</span> Chemical compound

Trimegestone, sold under the brand names Ondeva and Totelle among others, is a progestin medication which is used in menopausal hormone therapy and in the prevention of postmenopausal osteoporosis. It was also under development for use in birth control pills to prevent pregnancy, but ultimately was not marketed for this purpose. The medication is available alone or in combination with an estrogen. It is taken by mouth.

<span class="mw-page-title-main">Segesterone acetate</span> Progestin medication

Segesterone acetate (SGA), sold under the brand names Nestorone, Elcometrine, and Annovera, is a progestin medication which is used in birth control and in the treatment of endometriosis in the United States, Brazil, and other South American countries. It is available both alone and in combination with an estrogen. It is not effective by mouth and must be given by other routes, most typically as a vaginal ring or implant that is placed into fat.

<span class="mw-page-title-main">Hydroxyprogesterone heptanoate</span> Chemical compound

Hydroxyprogesterone heptanoate (OHPH), also known as hydroxyprogesterone enanthate (OHPE) and sold under the brand names H.O.P., Lutogil A.P., and Lutogyl A.P. among others, is a progestin medication used for progestogenic indications. It has been formulated both alone and in together with estrogens, androgens/anabolic steroids, and other progestogens in several combination preparations. OHPH is given by injection into muscle at regular intervals.

<span class="mw-page-title-main">Conjugated estrogens</span> Estrogen medication

Conjugated estrogens (CEs), or conjugated equine estrogens (CEEs), sold under the brand name Premarin among others, is an estrogen medication which is used in menopausal hormone therapy and for various other indications. It is a mixture of the sodium salts of estrogen conjugates found in horses, such as estrone sulfate and equilin sulfate. CEEs are available in the form of both natural preparations manufactured from the urine of pregnant mares and fully synthetic replications of the natural preparations. They are formulated both alone and in combination with progestins such as medroxyprogesterone acetate. CEEs are usually taken by mouth, but can also be given by application to the skin or vagina as a cream or by injection into a blood vessel or muscle.

<span class="mw-page-title-main">Estradiol (medication)</span> Steroidal hormone medication

Estradiol (E2) is a medication and naturally occurring steroid hormone. It is an estrogen and is used mainly in menopausal hormone therapy and to treat low sex hormone levels in women. It is also used in hormonal birth control for women, in hormone therapy for transgender women, and in the treatment of hormone-sensitive cancers like prostate cancer in men and breast cancer in women, among other uses. Estradiol can be taken by mouth, held and dissolved under the tongue, as a gel or patch that is applied to the skin, in through the vagina, by injection into muscle or fat, or through the use of an implant that is placed into fat, among other routes.

<span class="mw-page-title-main">Progesterone (medication)</span> Medication and naturally occurring steroid hormone

Progesterone (P4) is a medication and naturally occurring steroid hormone. It is a progestogen and is used in combination with estrogens mainly in hormone therapy for menopausal symptoms and low sex hormone levels in women. It is also used in women to support pregnancy and fertility and to treat gynecological disorders. Progesterone can be taken by mouth, in through the vagina, and by injection into muscle or fat, among other routes. A progesterone vaginal ring and progesterone intrauterine device used for birth control also exist in some areas of the world.

<span class="mw-page-title-main">Pharmacokinetics of estradiol</span>

The pharmacology of estradiol, an estrogen medication and naturally occurring steroid hormone, concerns its pharmacodynamics, pharmacokinetics, and various routes of administration.

The pharmacology of progesterone, a progestogen medication and naturally occurring steroid hormone, concerns its pharmacodynamics, pharmacokinetics, and various routes of administration.

<span class="mw-page-title-main">Pharmacokinetics of progesterone</span>

The pharmacokinetics of progesterone, concerns the pharmacodynamics, pharmacokinetics, and various routes of administration of progesterone.

<span class="mw-page-title-main">Pharmacokinetics of testosterone</span>

The pharmacology of testosterone, an androgen and anabolic steroid (AAS) medication and naturally occurring steroid hormone, concerns its pharmacodynamics, pharmacokinetics, and various routes of administration.

The Menopause, Estrogen and Venous Events (MEVE) study was a retrospective observational study of menopausal hormone therapy and venous thromboembolism (VTE) in postmenopausal women with a previous history of VTE. It found that transdermal estradiol was not associated with increased risk of VTE whereas oral estrogens were associated with a large increase in risk. The mean dose of transdermal estradiol in the study was 50 μg/day, although data on dose were missing for around 50% of women. Similarly, a small study found that transdermal estradiol did not influence coagulation in women with prior VTE. These findings are similar to studies in menopausal women without prior history of VTE which have found that transdermal estradiol has minimal influence on coagulation and is not associated with increased risk of VTE at doses of up to 100 μg/day. Menopausal hormone therapy guidelines have cited the MEVE study and recommended use of transdermal estradiol over oral estrogens in women at high risk for VTE. However, randomized controlled trials (RCTs) are still needed to definitively confirm findings that transdermal estradiol is safer than oral estrogens in terms of VTE risk.

References

  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. ↑ "Orbis Report - Lawley Pharmaceuticals". www.orbis.com. Bureau Van Dijk (BvD). Retrieved 16 December 2014.
  4. 1 2 Fooladi, Ensieh; Reuter, Stephanie E.; Bell, Robin J.; Robinson, Penelope J.; Davis, Susan R. (May 2014). "Pharmacokinetics of a transdermal testosterone cream in healthy postmenopausal women". Menopause. 22 (1): 44–49. doi:10.1097/GME.0000000000000259. PMID   24845394.
  5. ↑ El-Hage, G.; Eden, J. A.; Zoa Manga, R. (January 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): 335–343. doi:10.1080/13697130701364644. PMID   17653960.
  6. 1 2 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. ↑ "Michael Buckley's LinkedIn Profile". www.linkedin.com. LinkedIn Corporation. Retrieved 8 December 2014.
  8. ↑ "A Short Story by Michael Buckley the CEO of Lawley Pharmaceuticals" (PDF). www.lawleybasecamp.com. Lawley Pharmaceuticals Ltd. Retrieved 8 December 2014.
  9. ↑ "About Lawley Pharmaceuticals". www.lawleypharm.com.au. Lawley Pharmaceuticals Pty Ltd. Retrieved 8 December 2014.
  10. 1 2 "AndroFeme Testosterone Cream for women can improve the way you look and feel". www.completeherbalguide.co.vu. Guide to Natural Healing. Retrieved 19 December 2014.
  11. ↑ "Australian Approved Manufacturer". www.ebs.tga.gov.au/. TGA - Therapeutic Goods Administration. Retrieved 17 November 2014.
  12. ↑ "AndroForte 5 Transdermal cream". www.nps.org.au. National Prescribing Service Limited trading as NPS MedicineWise. Retrieved 16 December 2014.
  13. ↑ McCroy, Winnie. "AndroFeme Provides Hormone Replacement For Women". www.edgeboston.com. EDGE Publications, Inc. Retrieved 16 December 2014.
  14. ↑ "ARTG, PI and CMI results for Lawley Pharmaceuticals Products". www.tga.gov.au/. Australian Government, Department of Health, Therapeutic Goods Administration. Archived from the original on 8 December 2014. Retrieved 17 November 2014.
  15. ↑ "Public Summary: AndroFeme 1". www.tga.gov.au. Therapeutic Goods Administration. Retrieved 16 December 2014.
  16. ↑ "Public Summary: AndroForte 5". www.tga.gov.au. Therapeutic Goods Administration. Retrieved 16 December 2014.
  17. ↑ "Public Summary: ProFeme 10". www.tga.gov.au. Therapeutic Goods Administration. Retrieved 16 December 2014.
  18. ↑ 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.
  19. ↑ "Concord Hospital Research Report" (PDF). 2003. p. 38. Archived from the original (PDF) on 21 July 2008. Retrieved 4 February 2015.
  20. ↑ Handelsman, DJ. "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.
  21. ↑ Kelleher, S. "Long-Term Pharmacokinetics and Clinical Efficacy of Andromen ® Forte 5% Cream for Androgen Replacement Therapy in Hypogonadal Men". www.academia.edu. ANZAC Research Institute, Department of Andrology, Concord Hospital, Sydney, 2002.
  22. ↑ 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.
  23. ↑ 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.
  24. ↑ 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.
  25. ↑ 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.
  26. ↑ "How much testosterone is too much for women after menopause?". www.sciencedaily.com. ScienceDaily LLC.
  27. ↑ "Collaborative Study: Testosterone Antidepressant Augmentation in Women". www2.massgeneral.org/crp/. Massachusetts General Hospital Clinical Research Program. Archived from the original on 4 February 2015. Retrieved 4 February 2015.
  28. ↑ Buckley, Michael. "Lawley bio-identical research and clinical trials are happening around the world". www.hormonesolutions.com. Lawley Pharmaceuticals Ltd.
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