Product
Lybrel
Approval Date
May 22, 2007
Release Date
August 1, 2007
Company
Wyeth
Class
Oral contraceptive (progestin + estrogen)
Indication
Oral contraception.
Active Ingredient
Levonorgestrel 0.09mg, ethinyl estradiol 20micrograms (28tabs).
Agency Roster
Avenue A|Razorfish (professional and consumer)
MarketingStrategy/Execution
Lybrel is thefirst and only low dose combination contraceptive pill taken 365 days a year,without a placebo phase or pill-free interval. In comparison Bayer’s Yaz andWarner Chilcott’s Loestrin 24 shorten monthly periods to three days or less,and Duramed’s Seasonique, an updated version of Seasonale, reduces them to fourtimes a year. The ability to halt a woman’s menstrual periods indefinitely—althoughunscheduled bleeding or spotting can be common—has generated a fair amount ofnational media attention for the Wyeth brand. Analysts estimate Lybrel salescould reach $40 million by the end of 2007 and $235 million by 2010. Withinteractive specialist Avenue A|Razorfish handling consumer andprofessional promotion, expect extensive use of the online channel.
The Market
| O/C estrogen/progestogen US sales ($000s) last 5 years | |
| 2006 |
$3,044,517 |
| 2005 |
$2,837,655 |
| 2004 |
$2,750,102 |
| 2003 |
$2,821,448 |
| 2002 |
$2,684,818 |
| Source: IMS Health, Oct. 2007 |
|
| Top 5 O/C estrogen/progestogen | ||
| Jan.-July ’07 US sales ($000s) | % sales growth over Jan.-July ‘06 | |
|
YASMIN (Bayer) |
328,243 |
6 |
|
ORTHO-TRI-CY LO (Ortho-McNeil) |
240,018 |
3 |
|
YAZ (Bayer) |
109,126 |
>999 |
|
LOESTRIN 24 FE (Warner Chilcott) |
79,864 |
757 |
|
TRINESSA (Watson) |
74,652 |
-9 |
| Source: IMS Health, Oct. 2007 |
||
Physician Outlook
Study planned, 2008
Also in the Pipeline(according to Adis R&D Insight)
Drug: E2-Nomac monophasic/ EMM 310066
Manufacturer: Organon
Indication: Contraception
Active Ingredient: Estradiol/nomegestrolmonophasic
Phase: III
Source: Wolters Kluwer Health, Oct. 2007
Headliner:Gary Stiles of Wyeth
Ogilvylands Pfizer vet to develop CRM
Productnews from the 07/11/06 News Brief
TheTop 40: Grey Healthcare Group
Pharmacology
Lybrel is a non-cyclic oral contraceptive product that isgiven every day, without a hormone-free interval. Rather than experiencingwithdrawal bleeding on a monthly basis, patients using Lybrel do not haveregular menstrual cycles. However, unscheduled bleeding and spotting may occur.
Clinical Trials
The safety and efficacy of Lybrel were evaluated in 2 one-year trials. Thefirst study, which was a one-year open-label study conducted in North America,treated 2,134 patients (mean weight 70.38kg), of whom 1,213 discontinuedprematurely; 18% discontinued due to bleeding that was reported as either anadverse event or where bleeding was given as one of the reasons fordiscontinuation.
Among subjects =35 years old, there were 23 pregnancies during12,572 pill-packs of use (4 of which occurred in the 14-day period after thelast day of pill use), resulting in a total Pearl Index of 2.38 and a 1-yearlife table pregnancy rate of 2.39. Among those =35 years old who took the pillscompletely as directed, there were 15 pregnancies, resulting in a Pearl Indexof 1.55 and a one-year life table pregnancy rate of 1.59.
In a study conducted in Europe, 641patients (mean weight 63.86kg) were randomized to either Lybrel or a comparator(cyclic levonorgestrel 0.1mg + ethinyl estradiol 20mcg). One pregnancy occurredwithin the 14 days following the last dose of Lybrel, compared to 3 pregnanciesin the comparator group.
Adverse Reactions
Hypertension, nausea, vomiting, breakthrough bleeding,amenorrhea, transient delay in ovulation after discontinuation, edema,chloasma, mastodynia, headache, intolerance to contact lenses, increased riskof gallbladder disease, thromboembolic events.
Adults
Take at the same time each day.
1 tab daily (no tablet-free days). Start on Day 1 of cycle. Switching fromother contraceptives or post-partum: see literature; may need back-up methodfor 1st week.
Children
Premenarchal: not recommended.
Contraindications
Thrombophlebitis or thromboembolic disorders.Cerebrovascular or coronary artery disease. Valvular heart disease. Breast orother estrogen-dependent neoplasias. Undiagnosed abnormal genital bleeding.Cholestatic jaundice of pregnancy or jaundice with prior oral contraceptiveuse. Uncontrolled hypertension. Prolonged immobilization. Diabetes withvascular involvement. Headaches with focal neurological symptoms. Liver tumorsor disease. Pregnancy (Cat.X).
Precautions
Smokers >35 years old: not recommended. Hypertriglyceridemia.Discontinue if jaundice, visual disturbances, migraine, or other severeheadaches occur. Do regular complete physical exams. Nursing mothers: notrecommended.
Interactions
Antagonized by hepatic enzyme inducing drugs (eg, rifampin,griseofulvin, St. John’sWort, carbamazepine, phenytoin, protease inhibitors), others. Ethinyl estradiollevels may be increased by atorvastatin, CYP3A4 inhibitors, others. May affectmeasurement of sex hormone binding globulin levels.
