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NAMS Spotlight on New Therapies PDF Print
Written by Matthew Cluver   
Monday, 24 September 2007 10:57

< Do you want to know the latest updates on the the development of treatment options for menopause? We are pleased to share the following information from The North American Menopause Society. We will update this section frequently as the FDA provides more announcements.

The following is written by the North American Menopause Society :

By popular request, NAMS will provide ongoing information regarding new therapeutic options in menopause management. Note, however, that this mention does not imply endorsement.

March 2008--On March 3, The Wall Street Journal reported that Wyeth had received approval for Pristiq, the third antidepressant on the US market in a class known as serotonin-norepinephrine reuptake inhibitors (SNRIs), following Wyeth’s Effexor XR and Lilly’s Cymbalta. Wyeth is still seeking a separate indication for menopausal symptoms; that approval is delayed pending an additional year-long study. According to the report, the agency’s safety concerns aren’t a factor for Pristiq’s antidepressant use because the effective dose is much lower than for menopause symptoms.

January 2008—On January 7, an FDA Alert highlighted the possibility of severe musculoskeletal pain in patients using bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa). Although this adverse side effect is included in the prescribing information for all bisphosphonates, the FDA is concerned that the association between these therapeutic agents and severe musculoskeletal pain “may be overlooked by healthcare professionals, thereby delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.” The side effect may occur within days, months, or years after starting therapy. Some patients have reported complete relief of symptoms after discontinuation, whereas others have reported slow or incomplete resolution. Risk factors associated with this side effect are unknown. Severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgias, and arthralgias that sometimes accompanies initial administration of IV bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The FDA states that “healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.”

January 2008—An article in the January 8 issue of The Wall Street Journal reported that the FDA approved just 19 novel drugs during 2007, the lowest number since 1983. The article states that industry argues that the slowdown is the result of a tougher FDA, but the FDA says that its standards haven’t changed. Hypotheses for what may be driving the slowdown are presented: big pharma’s research labs are too bloated, bureaucratic, and risk averse; industry has shifted its focus away from novel drugs and toward tweaking existing medicines to maximize sales during the research drought; or maybe the easy drugs have been found and fresh scientific breakthroughs are needed before drug researchers can get traction again.”

December 2007—McNeil Personal Products Company has launched K-Y Brand Liquibeads, an OTC estrogen-free vaginal moisturizer that is delivered via vaginally inserted beads that “dissolve within minutes, then release to provide benefits for up to 4 days.”

December 2007—Bayer HealthCare announced that its Consumer Care Division has acquired from Mission Pharmacal Company its global Citracal line of OTC calcium supplements.

December 2007—Allergan, Inc. completed its acquisition of Esprit Pharma, Inc., marketer of Estrasorb (estradiol topical emulsion) for vasomotor symptoms associated with menopause and Sanctura XR (trospium chloride) for the treatment of overactive bladder.

November 2007—A press release dated November 19 announced that Schering-Plough Corporation had completed its acquisition of Organon BioSciences N.V., marketers of NuvaRing (etonogestrel/ethinyl estadiol) contraceptive ring and other brands.

October 2007—The October 8 issue of The Wall Street Journal reported that the European Union (EU) regulators have approved the Novartis bone drug, zolendronic acid, for postmenopausal osteoporosis. Marketed in the EU as Aclasta, the drug was recently approved for this indication in the United States as the brand name Reclast. (See September 2007 story below.)

October 2007—Duramed Pharmaceuticals, Inc., announced on October 2 that its synthetic conjugated estrogens, B (Enjuvia) is now indicated for treatment of moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy associated with menopause. This is the first and only oral estrogen FDA approved for the treatment of these specific symptoms. Enjuvia is already approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. In addition to launching the new indication, the
0.9 mg tablet strength, approved by the FDA in April, will now be added to the existing range of tablet dosing strengths.

September 2007—On September 14, the FDA approved Lilly’s raloxifene (Evista oral tablets) for a new use—reducing the risk of invasive breast cancer in two populations: (1) postmenopausal women with osteoporosis and (2) postmenopausal women at high risk for invasive breast cancer. Its decision was based on data from multiple trials, including STAR, RUTH, and MORE. In the STAR trial, for example, the observed incidence rates of invasive breast cancer per 1,000 women per year were 4.4 for raloxifene and 4.3 for tamoxifen, the first SERM approved for reducing the risk of invasive breast cancer. Raloxifene labeling states that the drug is not indicated for the treatment of existing breast cancer, reduction of the risk of recurrent breast cancer, or reduction of risk of noninvasive breast cancer. Raloxifene, a selective estrogen-receptor modulator (SERM), is already approved for the prevention and treatment of postmenopausal osteoporosis. Labeling contains a black-box warning of increased risk of venous thromboembolism and death from stroke.

September 2007—According to “The Pink Sheet,” Novartis received FDA approval of the osteoporosis treatment claim for zoledronic acid (Reclast Injection) on August 17. Labeling states that Reclast reduces the incidence of hip, vertebral, and nonvertebral osteoporosis-related fractures. The Swiss firm will seek an indication for prevention of clinical fractures after hip fracture. Reclast is the first once-yearly treatment for postmenopausal osteoporosis. A yearly 5 mg/100 mL IV infusion takes about 15 minutes. In April, Reclast was approved for treatment of Paget’s disease of the bone at the same dose. The single dose is reported to have a wholesale acquisition cost of $1,041. Zoledronic acid is also marketed by Novartis as Zometa (4 mg injection) for treatment of hypercalcemia of malignancy and multiple myeloma and bone metastases of solid tumors. Reclast is not yet available in Canada.

September 2007—The FDA has approved a new dosing option for using risedronate (Actonel), indicated for the prevention and treatment of osteoporosis. A 75 mg tablet is taken on two consecutive days each month rather than a 5 mg tablet taken daily. BMD increases are similar to those in women treated with the lower dose of daily Actonel at both 6 and 12 months. Actonel is marketed by The Alliance for Better Bone Health, a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis.

September 2007—The FDA has ruled that the term “selective estrogen-receptor modulator” (SERM) can no longer be used, and should be replaced with “estrogen agonist-antagonist.” No acronym has yet been suggested.

September 2007—In July, VIVUS, Inc. received FDA approval for Evamist, the first estradiol transdermal spray. It’s indicated for treatment of moderate to severe vasomotor symptoms. KV Pharmaceutical Company will market the product within its subsidiary, Ther-Rx Corporation. US launch is expected in early November.

August 2007—Zestra Laboratories announced on July 10 the results of its yet unpublished multi-site RCT of 296 women using its OTC nonhormonal Zestra Feminine Arousal Fluid for improving sexual experiences. The trial’s results, according to the marketer, show that the product is well tolerated and provides desire, arousal, and sexual satisfaction benefits. Zestra commented that the FDA does not require clinical trials for this type of product.

August 2007—According to “The Pink Sheet,” Wyeth received an “approvable” letter from the FDA on July 23 for a new nonhormonal treatment, desvenlafaxine (Pristiq), indicated for vasomotor symptoms. The FDA has requested an additional clinical trial that is at least a year in duration.

August 2007—“The Pink Sheet” also reported on July 30 that the FDA’s Oncologic Drugs Advisory Committee has voted to recommend approval of Lilly’s osteoporosis drug, raloxifene (Evista), for reducing invasive breast cancer risk in postmenopausal women with osteoporosis and postmenopausal women at high risk of breast cancer. This nonbinding recommendation awaits the FDA’s final ruling.

July 2007—Lil’ Drug Store Products, Inc., the marketers of Replens Long-Lasting Feminine Moisturizer, has announced the US launch of a new and novel vaginal lubricant: Intimate Options Personal Lubricant Mousse.
The company states that it has all the benefits of a vaginal lubricant without the typical unpleasant effects. The company’s recent market research study among 1,500 women revealed that the top five self-reported negative aspects of lubricants were: messiness (65.7%), messes up the bed (49.0%), drippy/doesn’t stay in place (43.3%), feels cold at initial application (41%), and interrupts the moment (25.7%). The company states that the new mousse product is light when dispensed, becoming smooth and silky on contact, and it does not run or become sticky. It is available in a 2-oz Unscented Personal Lubricant Mousse, a 2-oz Vanilla Personal Lubricant Mousse, and a 5.64-oz 2-in-1 Massage and Personal Lubricant Mousse with a hint of Vanilla Cinnamon.

July 2007—The FDA has approved OTC sale of the weight-loss prescription drug orlistat (Xenical, marketed
by Roche) as alli (GlaxoSmithKline) to be used in combination with a reduced-calorie, low-fat diet. The OTC product is available in half the strength of the Rx drug, in a starter pack of 90 60-mg capsules. Orlistat
prevents absorption of dietary fat (30% with 120 mg Xenical and 25% with 60 mg alli). A 16-wk controlled trial
(Anderson et al. Ann Pharmacother 2006) of 60 mg TID with meals in overweight (not obese) patients
(avg BMI 26.8) on a reduced-calorie, low-fat diet found that patients taking the drug lost 1.15 kg more than
those taking placebo. Orlistat causes flatulence with oily spotting, loose stools, and fecal urgency in 20%-40%
of patients on a low-fat diet. Side effects would presumably increase with higher doses or higher fat intake.
The drug also interferes with absorption of fat-soluble vitamins and possibly other drugs, and may increase the anticoagulant effect of warfarin.

June 2007—Upsher-Smith Laboratories, Inc., announced FDA approval for Divigel (estradiol gel), 0.1%, for the treatment of moderate to severe hot flashes associated with menopause. The company states that this new product offers the lowest approved dose of estradiol available for the treatment of these symptoms. It is estimated that the product will be commercially available in the United States in July.

June 2007—Novo Nordisk has announced the US launch of Activella 0.5 mg/0.1 mg (estradiol/norethindrone acetate) tablets, a new lower dose hormone therapy option for the treatment of moderate to severe menopause symptoms and prevention of postmenopausal osteoporosis. The company states that this is the lowest estradiol and norethindrone acetate combination commercially available in the United States.

Marketers of menopause therapies for North America are encouraged to forward to NAMS ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ) all press releases regarding new products and dosages.

Last Updated on Tuesday, 22 June 2010 15:51

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